Advanced Solid TumorPhase 1NCT04713891
A Study of KF-0210 in Advanced Solid Tumors Patients
A Phase 1 study testing KF-0210 tablets, 120 mg, KF-0210 tablets, 240 mg and KF-0210 tablets, 450 mg in people with Advanced Solid Tumor and Colorectal Cancer, run by Keythera Pharmaceuticals (Australia) Pty Ltd at 1 site in Australia.
Trial summary
The purpose of this Phase I, Multi-Center, Open-Label Study is to evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and anti-tumor activity of KF-0210 in participants with advanced solid tumors. The study will be conducted in two parts: phase Ia, and phase Ib. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Colorectal Cancer, Lung Cancer
- What is being tested?
- KF-0210 tablets, 120 mg, KF-0210 tablets, 240 mg and KF-0210 tablets, 450 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Mar 2021to 27 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, male and female;
- Patients are confirmed by available pathology records or current biopsy having advanced, nonresectable, or recurrent and progressing solid tumors since last anti-tumor therapy, and who are unavailable or intolerable for available standard therapy or there is no standard available therapy.
- Phase Ia (Dose Escalation): Advanced solid tumors;
- Phase Ib (Expansion Study): Patients must have any of the following tumor type and have not participated in Phase Ia trial of this study: CRC (MSS), LC, SCCE, GC, and BC. Among them, patients with LC, SCCE, or GC must have undergone PD-1/PD-L1 treatment for at least 12 weeks and failed.
- Must have at least 1 measurable lesion, according RECIST V1.1 criteria (CT-scans or MRI no longer than 4 weeks before signing ICF);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy≥ 3 months;
- Females must not be lactating or pregnant at screening or baseline (negative pregnant test).
Who cannot join
- Patients with prior anti-tumor therapy within 4 weeks prior to first dosing of KF-0210, including chemotherapy, biotherapy, endocrine therapy and immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer);
- Patients with prior definitive radiation therapy within 6 weeks prior to first dosing of KF-0210, and the irradiated lesions showed no signs of progression if it to be considered target lesions. Or patients with prior palliative radiotherapy within 2 weeks prior to first dosing of KF-0210. Or the radiotherapy-related side effects have unresolved before the study entry. Or use of radiopharmaceuticals (strontium, samarium) within 8 weeks prior to first dosing of KF-0210;
- Patients who have another active malignancy which is likely to require treatment;
- Patients who have known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the first dose of KF-0210; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation);
- Patients with any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma or history of syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy. Patients with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study;
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- Patients with inflammatory bowel disease or digestive tract diseases (e.g. peptic ulcer disease, including stomach and duodenal ulcer, gastritis and enteritis);
- Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of KF-0210;
- Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids except inhaled or intranasal corticosteroids (with minimal systemic absorption);
- Current use of NSAIDs, COX-1/COX-2 inhibitors within 4 weeks;
- Patients who have received surgical or interventional treatment (excluding tumor biopsy, puncture, etc.) within 28 days prior to first dosing of KF-0210;
- Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is shorter) prior to the first dosing of KF-0210;
- Use of any live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dosing of KF-0210;
- Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) grade 1 at the time of starting study treatment with exception of alopecia;
- Any uncontrolled or severe illness, including but not limited to: ongoing or active infection requiring parenteral antibiotics;
- Positive screening tests for any one of them: human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg); hepatitis B core antibody (HBcAb) (negative for HBsAg, but HBcAb positive, an HBV-DNA test will be performed and if positive will be excluded), hepatitis C antibody (anti-HCV positive, but negative HCV RNA test is allowed to be included).
Trial locations and contacts
1 site in 1 country.
Australia1 site
Scientia Clinical Research Limited
Randwick, New South Wales, 2031
About this study
Official title: A Phase I, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of KF-0210 in Patients With Advanced Solid Tumors
The purpose of this Phase I, Multi-Center, Open-Label Study is to evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and anti-tumor activity of KF-0210 in participants with advanced solid tumors. The study will be conducted in two parts: phase Ia, and phase Ib.
Read the detailed description
Phase 1a:
The primary objective of the phase 1a part of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and anti-tumor activity of oral KF-0210 as a single agent in participants with advanced solid tumors, to identify the dose-limiting toxicity and establish the maximum tolerated dose, or maximum administered dose and/or the recommended Phase II dose of KF-0210 in participants with advanced solid tumors.
Phase 1b:
The primary objective of the phase 1b part of the study is to assess the safety, pharmacokinetics, pharmacodynamic and anti-tumor activity of KF-0210 in combination with Atezolizumab in patients with colorectal cancer (CRC) (MSS), lung cancer (LC), squamous cell carcinoma of the esophagus (SCCE), gastric cancer (GC), and bladder cancer (BC).
- Conditions
- Advanced Solid Tumor, Colorectal Cancer, Lung Cancer, Squamous Cell Carcinoma of the Esophagus, Gastric Cancer, Bladder Cancer
- Being tested
- KF-0210 tablets, 120 mg, KF-0210 tablets, 240 mg, KF-0210 tablets, 450 mg, KF-0210 tablets, 600 mg, KF-0210 (dosage RP2D-2) + Atezolizumab
- Medical subject headings
- Colorectal Neoplasms, Lung Neoplasms, Esophageal Squamous Cell Carcinoma, Stomach Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KF-0210 tablets, 120 mgDrug
Also called KF-0210-0
KF-0210 tablet will be orally administered as a single agent at 120 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
KF-0210 tablets, 240 mgDrug
Also called KF-0210-0
KF-0210 tablet will be orally administered as a single agent at 240 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
KF-0210 tablets, 450 mgDrug
Also called KF-0210-0
KF-0210 tablet will be orally administered as a single agent at 450 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
KF-0210 tablets, 600 mgDrug
Also called KF-0210-0
KF-0210 tablet will be orally administered as a single agent at 600 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
KF-0210 (dosage RP2D-2) + AtezolizumabDrug
Also called KF-0210-0, Tecentriq
KF-0210 tablet will be orally administered at dosage RP2D-2 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.
KF-0210 (dosage RP2D-1) + AtezolizumabDrug
Also called KF-0210-0, Tecentriq
KF-0210 tablet will be orally administered at dosage RP2D-1 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.
KF-0210 (dosage RP2D) + AtezolizumabDrug
Also called KF-0210-0, Tecentriq
KF-0210 tablet will be orally administered at dosage RP2D once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Cohort 1 | Experimental | KF-0210 tablet will be administered at 120 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal. Receives: Drug: KF-0210 tablets, 120 mg |
| Phase 1a: Cohort 2 | Experimental | KF-0210 tablet will be administered at 240 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal. Receives: Drug: KF-0210 tablets, 240 mg |
| Phase 1a: Cohort 3 | Experimental | KF-0210 tablet will be administered at 450 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal. Receives: Drug: KF-0210 tablets, 450 mg |
| Phase 1a: Cohort 4 | Experimental | KF-0210 tablet will be administered at 600 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal. Receives: Drug: KF-0210 tablets, 600 mg |
| Phase Ib, Cohort 1 | Experimental | KF-0210 (dose RP2D-2, orally once daily)+ Atezolizumab (1200 mg every 3 weeks) continuously until disease progression/recurrence or death from any cause, or serious adverse events (SAE) observed (whichever occurs earlier) for up to 2 years. Receives: Drug: KF-0210 (dosage RP2D-2) + Atezolizumab |
| Phase Ib, Cohort 2 | Experimental | KF-0210 (dose RP2D-1, orally once daily)+ Atezolizumab (1200 mg every 3 weeks) continuously until disease progression/recurrence or death from any cause, or serious adverse events (SAE) observed (whichever occurs earlier) for up to 2 years. Receives: Drug: KF-0210 (dosage RP2D-1) + Atezolizumab |
| Phase Ib, Cohort 3 | Experimental | KF-0210 (dose RP2D, orally once daily)+ Atezolizumab (1200 mg every 3 weeks) continuously until disease progression/recurrence or death from any cause, or serious adverse events (SAE) observed (whichever occurs earlier) for up to 2 years. Receives: Drug: KF-0210 (dosage RP2D) + Atezolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patient with adverse events / serious adverse events (AEs/SAEs) [Safety and Tolerability]
Adverse events will be assessed according to CTCAE V5.0, and be coded according to the MedDRA Dictionary
Measured: From consent through 28 days (±7 days) after the last dose or before starting other anti-tumor treatment (whichever occurs earlier)(up to approximately 1 year))
Dose limiting toxicity (DLT) of KF-0210 [Tolerability]
Dose limiting toxicity (DLT) will be considered to be related to KF-0210 according to CTCAE V5.0 including hematology toxicities, non-hematological toxicities and any other toxicities.
Measured: From Cycle 1 Day 1 to Cycle 1 Day 21, each cycle is 21 days.
Maximum tolerated dose (MTD) of KF-0210 alone [Tolerability]
The Maximum tolerated dose (MTD) is defined as the highest dose at which ≤1、6 participants occurred dose limiting toxicity at each dose level.
Measured: Up to 21 days after first administration in cycle 1, each cycle is 21 days
Change of Body Weight from Baseline [Safety]
Body Weight measured in kilogram (kg)
Measured: On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Body Temperature from Baseline [Safety]
Axillary temperature measured in celsius
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of Pulse rate from Baseline [Safety]
Pulse rate measured per minute
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of Systolic pressure from Baseline [Safety]
Blood pressure measured in mmHg
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of Diastolic pressure from Baseline [Safety]
Blood pressure measured in mmHg
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of Heart rate from Baseline [Safety]
Heart rate in beats per minute (Bpm) through 12-lead ECG assessment
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of R-R interval from Baseline [Safety]
R-R interval measured in millisecond through 12-lead ECG assessment
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of P-R interval from Baseline [Safety]
P-R interval measured in millisecond through 12-lead ECG assessment
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of QRS complex from Baseline [Safety]
QRS complex measured in millisecond through 12-lead ECG assessment
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Chang of QT interval from Baseline [Safety]
QT interval measured in millisecond through 12-lead ECG assessment
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of corrected QT (QTc) interval from Baseline [Safety]
corrected QT (QTc) interval measured in millisecond through 12-lead ECG assessment
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of Fridericia's Correction QT (QTcF) interval from Baseline [Safety]
Fridericia's Correction QT (QTcF) interval measured in millisecond through 12-lead ECG assessment.
Measured: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Change of Eastern Cooperative Oncology Group-Performance Status (ECOG PS) from Baseline [Safety]
The performance status will be evaluated in accordance with the Eastern Cooperative Oncology Group (ECOG) criteria with the score range in 0 to 5. A score of 0 represents fully normal activity and a score of 5 represents death.
Measured: On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Total Protein (TP) from Baseline [Safety]
Total Protein (TP) measured in g/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Albumin (ALB) from Baseline [Safety]
Albumin(ALB) measured in g/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Alanine aminotransferase (ALT) from Baseline [Safety]
Alanine aminotransferase (ALT) measured in IU/L
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Aspartate aminotransferase (AST) from Baseline [Safety]
Aspartate aminotransferase (AST) measured in IU/L
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Alkaline phosphatase (ALP/AKP) from Baseline [Safety]
Alkaline phosphatase (ALP/AKP) measured in IU/L
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Total bilirubin from Baseline [Safety]
Total bilirubin measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Direct bilirubin from Baseline [Safety]
Direct bilirubin measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Indirect bilirubin from Baseline [Safety]
Indirect bilirubin measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Glutamyl transpeptidase from Baseline [Safety]
Glutamyl transpeptidase measured in U/L
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Blood glucose from Baseline [Safety]
Blood glucose measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Urea from Baseline [Safety]
Urea measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Uric acid from Baseline [Safety]
Uric acid measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Creatinine from Baseline [Safety]
Creatinine measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Creatinine Kinase from Baseline [Safety]
Creatinine Kinase measured in IU/L
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Total Cholesterol from Baseline [Safety]
Total Cholesterol measured in mmol/L
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Triglycerides from Baseline [Safety]
Triglycerides measured in mmol/L
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Potassium, Sodium, Chloride or Calcium from Baseline [Safety]
Potassium, Sodium, Chloride or Calcium measured in mmol/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Leukocyte Count from Baseline [Safety]
Leukocyte Count measured in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Neutrophil Count from Baseline [Safety]
Neutrophil Count in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Percentage of Neutrophil from Baseline [Safety]
Percentage of Neutrophil will be measured
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Lymphocyte Count from Baseline [Safety]
Lymphocyte Count measured in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Percentage of Lymphocyte from Baseline [Safety]
Percentage of Lymphocyte will be measured
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Monocytes Count from Baseline [Safety]
Monocytes Count measured in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Percentage of Monocytes from Baseline [Safety]
Percentage of Monocytes will be measured
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Eosinophils Count from Baseline [Safety]
Eosinophils Count measured in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Percentage of Eosinophils from Baseline [Safety]
Percentage of Eosinophils will be measured
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Basophil Count from Baseline [Safety]
Basophil Count measured in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Percentage of Basophil from Baseline [Safety]
Percentage of Basophil will be measured
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Erythrocyte Count from Baseline [Safety]
Erythrocyte Count measured in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Hemoglobin from Baseline [Safety]
Hemoglobin measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Hematocrit Platelets from Baseline [Safety]
Hematocrit Platelets measured in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Coagulation test-Activated partial thromboplastin time (APTT) from Baseline [Safety]
Activated partial thromboplastin time (APTT) measured in seconds
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Coagulation test-Prothrombin time (PT) from Baseline [Safety]
Prothrombin time (PT) measured in seconds
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Coagulation test-Fibrinogen(FIB) from Baseline [Safety]
Fibrinogen(FIB) measured in mmol/L
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Coagulation test-Thrombin time (TT) from Baseline [Safety]
Thrombin time (TT) measured in seconds
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Urine pH from Baseline [Safety]
pH value will be measured
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change of Specific gravity of urine from Baseline [Safety]
Specific gravity value will be measured
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change in Occult blood result from Baseline [Safety]
The result will be recorded as either positive or negative
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change in Urine Bilirubin result from Baseline [Safety]
Urine bilirubin will be measure in µmol/L
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change in Urine protein from Baseline [Safety]
Urine protein will be measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change in Urine Glucose from Baseline [Safety]
Urine Glucose will be measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change in Ketones from Baseline [Safety]
Ketones will be measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change in Urobilinogen from Baseline [Safety]
Urobilinogen will be measured in EU/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change in Urinary leukocyte from Baseline [Safety]
Urinary leukocyte will be counted in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change in Urine erythrocytes from Baseline [Safety]
Urine erythrocytes will be counted in K/uL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Change in Urine Nitrites from Baseline [Safety]
Urobilinogen will be measured in mg/dL
Measured: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Clinically significant abnormality in physical examinations
Physical examination includes skin, head, eyes, ears, nose and throat, lymph nodes, heart, chest, abdomen and extremities, and nervous system (speech, cranial nerves, motor ability, tendon reflexes, sensations, free movement)
Measured: On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
Secondary outcomes (15)
Maximum observed plasma concentration (Cmax)
For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above).
Measured: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 5, each cycle is 21 days.
Time of maximum plasma concentration (Tmax)
For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above).
Measured: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above).
Measured: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-t) of KF-0210
For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above).
Measured: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Terminal half-life (T1/2) of KF-0210
For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above).
Measured: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Accumulation ratio (Rac)
For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above).
Measured: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Cmin to Cmax fluctuation between dose time and Tau (DF)
For KF-0210 alone in phase Ia, and for KF-0210 and Atezolizumab in Phase Ib. Calculated by non-compartmental analysis (NCA) for WinNonlin V8.2 (or above).
Measured: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Blood cytokines/chemokines levels
Biomarker for pharmacodynamic assessment including interferon (IFN-γ), tumor necrosis factor (TNF-α), CXCL10 and CCL5.
Measured: Up to 21 days after first administration in cycle 1, each cycle is 21 days.
Urine prostaglandin metabolites level
To explore the prostaglandin metabolites in urine
Measured: Up to 21 days after first administration in cycle 1, each cycle is 21 days.
Tumor T cell infiltration
Tumor biopsies will be analyzed by immunohistochemistry (IHC) for CD3+ T cells, CD8+ T cells and PD-L1 expression.
Measured: Up to 21 days after first administration in cycle 1, each cycle is 21 days.
Change in tumor size from baseline
Tumor assessment with CT scan or MRI. The anti-tumor activity will be evaluated according to the RECIST V1.1.
Measured: From screening through the last dose of treatment, each cycle is 21 days.
Objective response rate (ORR)
Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD).
Measured: From screening through the last dose of treatment, each cycle is 21 days.
Duration of response (DOR) (days)
Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD).
Measured: From screening through the last dose of treatment, each cycle is 21 days.
Disease control rate (DCR)
Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD).
Measured: From screening through the last dose of treatment, each cycle is 21 days.
Progression free survival (PFS)
Tumor assessment with CT scan or MRI. The tumor lesions will be evaluated according to the RECIST V1.1 standard, and categorized into complete response(CR), partial response (PR), stable disease (SD) , and progressive disease (PD).
Measured: From screening through the last dose of treatment, each cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start9 Mar 2021
- Primary completion8 Dec 2022
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keythera Pharmaceuticals (Australia) Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rasha Cosman, MD, Principal investigator, Scientia Clinical Research Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713891
- Sponsor's protocol ID
- KFCS001
- Status last verified
- Oct 2022
- First submitted
- 25 Nov 2020
- Last updated
- 24 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of KF-0210 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04713891
- Acronym / sponsor ID
- KFCS001
- Conditions
- Advanced Solid Tumor, Colorectal Cancer, Lung Cancer, Squamous Cell Carcinoma of the Esophagus, Gastric Cancer, Bladder Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Keythera Pharmaceuticals (Australia) Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this Phase I, Multi-Center, Open-Label Study is to evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and anti-tumor activity of KF-0210 in participants with advanced solid tumors. The study will be conducted in two parts: phase Ia, and phase Ib.
Detailed description
Phase 1a:
The primary objective of the phase 1a part of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and anti-tumor activity of oral KF-0210 as a single agent in participants with advanced solid tumors, to identify the dose-limiting toxicity and establish the maximum tolerated dose, or maximum administered dose and/or the recommended Phase II dose of KF-0210 in participants with advanced solid tumors.
Phase 1b:
The primary objective of the phase 1b part of the study is to assess the safety, pharmacokinetics, pharmacodynamic and anti-tumor activity of KF-0210 in combination with Atezolizumab in patients with colorectal cancer (CRC) (MSS), lung cancer (LC), squamous cell carcinoma of the esophagus (SCCE), gastric cancer (GC), and bladder cancer (BC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Cohort 1 | Experimental | Drug: KF-0210 tablets, 120 mgKF-0210 tablet will be administered at 120 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal. |
| Phase 1a: Cohort 2 | Experimental | Drug: KF-0210 tablets, 240 mgKF-0210 tablet will be administered at 240 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal. |
| Phase 1a: Cohort 3 | Experimental | Drug: KF-0210 tablets, 450 mgKF-0210 tablet will be administered at 450 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal. |
| Phase 1a: Cohort 4 | Experimental | Drug: KF-0210 tablets, 600 mgKF-0210 tablet will be administered at 600 mg as a single agent orally once daily (QD) continuously in cycles (1 cycle=21 days) until the disease progression, intolerance, or informed consent withdrawal. |
| Phase Ib, Cohort 1 | Experimental | Drug: KF-0210 (dosage RP2D-2) + AtezolizumabKF-0210 (dose RP2D-2, orally once daily)+ Atezolizumab (1200 mg every 3 weeks) continuously until disease progression/recurrence or death from any cause, or serious adverse events (SAE) observed (whichever occurs earlier) for up to 2 years. |
| Phase Ib, Cohort 2 | Experimental | Drug: KF-0210 (dosage RP2D-1) + AtezolizumabKF-0210 (dose RP2D-1, orally once daily)+ Atezolizumab (1200 mg every 3 weeks) continuously until disease progression/recurrence or death from any cause, or serious adverse events (SAE) observed (whichever occurs earlier) for up to 2 years. |
| Phase Ib, Cohort 3 | Experimental | Drug: KF-0210 (dosage RP2D) + AtezolizumabKF-0210 (dose RP2D, orally once daily)+ Atezolizumab (1200 mg every 3 weeks) continuously until disease progression/recurrence or death from any cause, or serious adverse events (SAE) observed (whichever occurs earlier) for up to 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years old, male and female;
- Patients are confirmed by available pathology records or current biopsy having advanced, nonresectable, or recurrent and progressing solid tumors since last anti-tumor therapy, and who are unavailable or intolerable for available standard therapy or there is no standard available therapy.
- Must have at least 1 measurable lesion, according RECIST V1.1 criteria (CT-scans or MRI no longer than 4 weeks before signing ICF);
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Life expectancy≥ 3 months;
Key exclusion criteria (16 listed)
- Patients with prior anti-tumor therapy within 4 weeks prior to first dosing of KF-0210, including chemotherapy, biotherapy, endocrine therapy and immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer);
- Patients with prior definitive radiation therapy within 6 weeks prior to first dosing of KF-0210, and the irradiated lesions showed no signs of progression if it to be considered target lesions. Or patients with prior palliative radiotherapy within 2 weeks prior to first dosing of KF-0210. Or the radiotherapy-related side effects have unresolved before the study entry. Or use of radiopharmaceuticals (strontium, samarium) within 8 weeks prior to first dosing of KF-0210;
- Patients who have another active malignancy which is likely to require treatment;
- Patients who have known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the first dose of KF-0210; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KF-0210 tablets, 120 mgAlso: KF-0210-0KF-0210 tablet will be orally administered as a single agent at 120 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal. | Drug | Phase 1a: Cohort 1 |
| KF-0210 tablets, 240 mgAlso: KF-0210-0KF-0210 tablet will be orally administered as a single agent at 240 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal. | Drug | Phase 1a: Cohort 2 |
| KF-0210 tablets, 450 mgAlso: KF-0210-0KF-0210 tablet will be orally administered as a single agent at 450 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal. | Drug | Phase 1a: Cohort 3 |
| KF-0210 tablets, 600 mgAlso: KF-0210-0KF-0210 tablet will be orally administered as a single agent at 600 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal. | Drug | Phase 1a: Cohort 4 |
| KF-0210 (dosage RP2D-2) + AtezolizumabAlso: KF-0210-0, TecentriqKF-0210 tablet will be orally administered at dosage RP2D-2 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion. | Drug | Phase Ib, Cohort 1 |
| KF-0210 (dosage RP2D-1) + AtezolizumabAlso: KF-0210-0, TecentriqKF-0210 tablet will be orally administered at dosage RP2D-1 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion. | Drug | Phase Ib, Cohort 2 |
| KF-0210 (dosage RP2D) + AtezolizumabAlso: KF-0210-0, TecentriqKF-0210 tablet will be orally administered at dosage RP2D once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion. | Drug | Phase Ib, Cohort 3 |
Primary outcome
Percentage of patient with adverse events / serious adverse events (AEs/SAEs) [Safety and Tolerability]
Time frame: From consent through 28 days (±7 days) after the last dose or before starting other anti-tumor treatment (whichever occurs earlier)(up to approximately 1 year))
Adverse events will be assessed according to CTCAE V5.0, and be coded according to the MedDRA Dictionary
Dose limiting toxicity (DLT) of KF-0210 [Tolerability]
Time frame: From Cycle 1 Day 1 to Cycle 1 Day 21, each cycle is 21 days.
Dose limiting toxicity (DLT) will be considered to be related to KF-0210 according to CTCAE V5.0 including hematology toxicities, non-hematological toxicities and any other toxicities.
Maximum tolerated dose (MTD) of KF-0210 alone [Tolerability]
Time frame: Up to 21 days after first administration in cycle 1, each cycle is 21 days
The Maximum tolerated dose (MTD) is defined as the highest dose at which ≤1、6 participants occurred dose limiting toxicity at each dose level.
Change of Body Weight from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
Body Weight measured in kilogram (kg)
Change of Body Temperature from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Axillary temperature measured in celsius
Change of Pulse rate from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Pulse rate measured per minute
Change of Systolic pressure from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Blood pressure measured in mmHg
Change of Diastolic pressure from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Blood pressure measured in mmHg
Change of Heart rate from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Heart rate in beats per minute (Bpm) through 12-lead ECG assessment
Change of R-R interval from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
R-R interval measured in millisecond through 12-lead ECG assessment
Change of P-R interval from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
P-R interval measured in millisecond through 12-lead ECG assessment
Change of QRS complex from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
QRS complex measured in millisecond through 12-lead ECG assessment
Chang of QT interval from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
QT interval measured in millisecond through 12-lead ECG assessment
Change of corrected QT (QTc) interval from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
corrected QT (QTc) interval measured in millisecond through 12-lead ECG assessment
Change of Fridericia's Correction QT (QTcF) interval from Baseline [Safety]
Time frame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
Fridericia's Correction QT (QTcF) interval measured in millisecond through 12-lead ECG assessment.
Change of Eastern Cooperative Oncology Group-Performance Status (ECOG PS) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
The performance status will be evaluated in accordance with the Eastern Cooperative Oncology Group (ECOG) criteria with the score range in 0 to 5. A score of 0 represents fully normal activity and a score of 5 represents death.
Change of Total Protein (TP) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Total Protein (TP) measured in g/dL
Change of Albumin (ALB) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Albumin(ALB) measured in g/dL
Change of Alanine aminotransferase (ALT) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Alanine aminotransferase (ALT) measured in IU/L
Change of Aspartate aminotransferase (AST) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Aspartate aminotransferase (AST) measured in IU/L
Change of Alkaline phosphatase (ALP/AKP) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Alkaline phosphatase (ALP/AKP) measured in IU/L
Change of Total bilirubin from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Total bilirubin measured in mg/dL
Change of Direct bilirubin from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Direct bilirubin measured in mg/dL
Change of Indirect bilirubin from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Indirect bilirubin measured in mg/dL
Change of Glutamyl transpeptidase from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Glutamyl transpeptidase measured in U/L
Change of Blood glucose from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Blood glucose measured in mg/dL
Change of Urea from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Urea measured in mg/dL
Change of Uric acid from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Uric acid measured in mg/dL
Change of Creatinine from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Creatinine measured in mg/dL
Change of Creatinine Kinase from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Creatinine Kinase measured in IU/L
Change of Total Cholesterol from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Total Cholesterol measured in mmol/L
Change of Triglycerides from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Triglycerides measured in mmol/L
Change of Potassium, Sodium, Chloride or Calcium from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Potassium, Sodium, Chloride or Calcium measured in mmol/dL
Change of Leukocyte Count from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Leukocyte Count measured in K/uL
Change of Neutrophil Count from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Neutrophil Count in K/uL
Change of Percentage of Neutrophil from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Percentage of Neutrophil will be measured
Change of Lymphocyte Count from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Lymphocyte Count measured in K/uL
Change of Percentage of Lymphocyte from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Percentage of Lymphocyte will be measured
Change of Monocytes Count from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Monocytes Count measured in K/uL
Change of Percentage of Monocytes from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Percentage of Monocytes will be measured
Change of Eosinophils Count from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Eosinophils Count measured in K/uL
Change of Percentage of Eosinophils from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Percentage of Eosinophils will be measured
Change of Basophil Count from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Basophil Count measured in K/uL
Change of Percentage of Basophil from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Percentage of Basophil will be measured
Change of Erythrocyte Count from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Erythrocyte Count measured in K/uL
Change of Hemoglobin from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Hemoglobin measured in mg/dL
Change of Hematocrit Platelets from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Hematocrit Platelets measured in K/uL
Change of Coagulation test-Activated partial thromboplastin time (APTT) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Activated partial thromboplastin time (APTT) measured in seconds
Change of Coagulation test-Prothrombin time (PT) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Prothrombin time (PT) measured in seconds
Change of Coagulation test-Fibrinogen(FIB) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Fibrinogen(FIB) measured in mmol/L
Change of Coagulation test-Thrombin time (TT) from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Thrombin time (TT) measured in seconds
Change of Urine pH from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
pH value will be measured
Change of Specific gravity of urine from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Specific gravity value will be measured
Change in Occult blood result from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
The result will be recorded as either positive or negative
Change in Urine Bilirubin result from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Urine bilirubin will be measure in µmol/L
Change in Urine protein from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Urine protein will be measured in mg/dL
Change in Urine Glucose from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Urine Glucose will be measured in mg/dL
Change in Ketones from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Ketones will be measured in mg/dL
Change in Urobilinogen from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Urobilinogen will be measured in EU/dL
Change in Urinary leukocyte from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Urinary leukocyte will be counted in K/uL
Change in Urine erythrocytes from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Urine erythrocytes will be counted in K/uL
Change in Urine Nitrites from Baseline [Safety]
Time frame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
Urobilinogen will be measured in mg/dL
Clinically significant abnormality in physical examinations
Time frame: On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
Physical examination includes skin, head, eyes, ears, nose and throat, lymph nodes, heart, chest, abdomen and extremities, and nervous system (speech, cranial nerves, motor ability, tendon reflexes, sensations, free movement)
15 secondary outcomes
Maximum observed plasma concentration (Cmax)
Time frame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 5, each cycle is 21 days.
Time of maximum plasma concentration (Tmax)
Time frame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
Time frame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-t) of KF-0210
Time frame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Terminal half-life (T1/2) of KF-0210
Time frame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Accumulation ratio (Rac)
Time frame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Cmin to Cmax fluctuation between dose time and Tau (DF)
Time frame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
Blood cytokines/chemokines levels
Time frame: Up to 21 days after first administration in cycle 1, each cycle is 21 days.
Urine prostaglandin metabolites level
Time frame: Up to 21 days after first administration in cycle 1, each cycle is 21 days.
Tumor T cell infiltration
Time frame: Up to 21 days after first administration in cycle 1, each cycle is 21 days.
Change in tumor size from baseline
Time frame: From screening through the last dose of treatment, each cycle is 21 days.
Objective response rate (ORR)
Time frame: From screening through the last dose of treatment, each cycle is 21 days.
Duration of response (DOR) (days)
Time frame: From screening through the last dose of treatment, each cycle is 21 days.
Disease control rate (DCR)
Time frame: From screening through the last dose of treatment, each cycle is 21 days.
Progression free survival (PFS)
Time frame: From screening through the last dose of treatment, each cycle is 21 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasha Cosman, MD principal investigator
Scientia Clinical Research Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KF-0210 tablets, 120 mg, KF-0210 tablets, 240 mg and KF-0210 tablets, 450 mg in people with Advanced Solid Tumor and Colorectal Cancer, run by Keythera Pharmaceuticals (Australia) Pty Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patient with adverse events / serious adverse events (AEs/SAEs) [Safety and Tolerability] (time frame: From consent through 28 days (±7 days) after the last dose or before starting other anti-tumor treatment (whichever occurs earlier)(up to approximately 1 year))). The study lists 63 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.