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Advanced Solid TumorPhase 1NCT04093466

A Phase 1 Study of CX1003 (Kanitinib) in Patients with Advanced Solid Tumors

A Phase 1 study testing CX1003 in people with Advanced Solid Tumor, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

CX1003 is a novel multi-target tyrosine kinase inhibitor that is designed to primarily inhibit vascular endothelial growth factor receptor 2 (VEGFR2) and hepatocyte growth factor receptor (HGFR/MET). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
CX1003
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
1 siteChina
Study dates
27 Apr 2020to Dec 2025
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

  • Histologically or cytologically confirmed recurrent or metastatic solid tumors;
  • At least one measurable lesion (spiral CT scan long diameter ≥10 mm or enlarged lymph node short diameter ≥15 mm by RECIST 1.1);
  • Documented disease progression after, or refractory to, or intolerant of prior standard or established therapy known to provide clinical benefit for their condition; or documented disease progression within 24 weeks after prior adjuvant/neoadjuvant therapy;
  • ECOG PS ≤1;
  • Expected overall survival≥12 weeks;

Who cannot join

  • Untreated brain metastases or symptoms of brain metastases cannot be controlled more than 4 weeks;
  • Other kinds of malignancies [excluding stage IB or lower grade cervical cancer，noninvasive basal cell or squamous cell cancer, breast cancer with complete remission (CR) > 10 years ,melanoma with CR > 10 years or other malignant tumors with CR > 5 years];
  • Hematologic, renal, and hepatic function abnormities as defined below:
  • Absolute neutrophil count (ANC) <1.5×109 /L or platelet <100×109 /L or hemoglobin <9 g/dL; Total bilirubin > 1.5×the upper limit of normal range(ULN) without liver metastases; total bilirubin > 3×ULN with liver metastases; AST, ALT, ALP >1.5×ULN without liver metastases ; AST, ALT, ALP >5×ULN with liver metastases; Primary hepatocellular carcinoma; Hepatic cirrhosis with Child-Pugh B or C; Serum creatinine >1.5×ULN; History of previous nephrotic syndrome; INR or aPPT >1.5×ULN; Presence of hemorrhage (hemoptysis) , thrombosis，or currently receiving treatment with warfarin, aspirin, low molecular weight heparin (LMWH), or any other anti-platelet drugs (Aspirin ≤100 mg/d for prophylaxis are allowed); •Any of the following gastrointestinal disease: Unable to swallow oral drugs; Need intravenous nutrition; History of a gastric resection; History of treatment for active peptic ulcer disease within 6 months; Clinically significant gastrointestinal bleeding within 3 months; Persistent grade 2 or higher chronic diarrhea despite optimal medical management;
  • •Any of the following cardiovascular and cerebrovascular disease: Myocardial infarction , severe cardiac arrhythmias, unstable angina, coronary artery disease, congestive heart failure, cerebrovascular accident or TIA within 12 months ; Deep vein thrombosis or pulmonary embolism within 6 months; QTcF >470 msec; Uncontrolled hypertension despite optimal medical management;
  • Presence of unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v5.0 grade 0 or 1 with the exception of alopecia;
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  • Involved in other clinical trials within 30 days of enrollment;
  • Major surgical procedure, open biopsy, or significant traumatic injury within 30 days of enrollment;
  • History of organ allograft ;
  • Need glucocorticoids or other immunosuppressive agents for immunosuppression (excluding local or inhaled glucocorticoids);
  • Uncontrolled ongoing or active infection;
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy;
  • Pregnant or lactating women or those who do not take contraceptives, including men;
  • Suffering from mental and neurological diseases;
  • Any other metabolic dysfunction, abnormal physical examination findings, or clinical laboratory findings;
  • Inability to comply with protocol required procedures.

Trial locations and contacts

1 site in 1 country.

Junyu Wu, Ph.D contact

0086-10-53056686 ext. 2063

wujy@konruns.cn

China1 site, 1 recruiting

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, Dr, 008610-87788507, syuankai@cicams.ac.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase 1, Multicenter, Open-label, Dose Escalation/expansion Study Evaluating the Safety, Pharmacokinetics and Preliminary Efficacy of CX1003 (Kanitinib) in the Patients with Relapsed Advanced or Metastatic Solid Tumors

CX1003 is a novel multi-target tyrosine kinase inhibitor that is designed to primarily inhibit vascular endothelial growth factor receptor 2 (VEGFR2) and hepatocyte growth factor receptor (HGFR/MET). This study aimed to evaluate the safety, pharmacokinetics, and antitumor activity of CX1003 in patients with refractory advanced or metastatic solid tumors.

Being tested
CX1003

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CX1003Drug

    Also called kanitinib

    Oral dose A 4-day single dose period, followed by a period of daily-dose in continuous 28-day treatment cycle (the 1st cycle) or 21-day treatment cycles (the 2nd cycle and beyond) Dosage range: 25 mg, 50mg, 75mg, 100mg,125mg,150mg,175mg

Study groups in NCT04093466
Study groupRoleWhat they receive
Treatment (CX1003)ExperimentalTreatment will comprise 2 periods: a 4-day single dose period, followed by a period of daily-dose in continuous 28-day treatment cycle (the 1st cycle) or 21-day treatment cycles (the 2nd cycle and beyond).
Receives: Drug: CX1003

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicities (DLTs) by NCI CTCAE 5.0: Dose Escalation Stage

    Occurrence of any of the following toxicities was considered DLT if judged by the Investigator to be possibly, probably, or definitely related to the administration of CX1003:

    • Any Grade 3 or higher non-hematologic toxicity (including persisting nausea, vomiting, diarrhea, and electrolyte imbalances despite optimal medical management);
    • Grade 4 neutropenia for >5 consecutive days;
    • Grade 3 or higher febrile neutropenia;
    • Grade 3 or higher neutropenia associated with infection;
    • Grade 4 thrombocytopenia;
    • Grade 3 or higher thrombocytopenia with clinically significant bleeding or that requires a platelet transfusion.

    Measured: First 5 weeks after initial administration of CX1003

  2. Maximum tolerated dose (MTD): Dose Escalation Stage

    The maximum tolerated dose (MTD) was defined as the highest dose for a given schedule that was expected to cause DLTs in no more than 33% of patients.

    Measured: First 5 weeks after initial administration of CX1003

Secondary outcomes (11)

  1. Pharmacokinetics (PK) profile: Cmax

    Parameters: Peak Plasma Concentration (Cmax)

    Measured: First 5 weeks after initial administration of CX1003

  2. Pharmacokinetics (PK) profile: Tmax

    Parameters: Time to reach the maximum plasma concentration (Tmax)

    Measured: First 5 weeks after initial administration of CX1003

  3. Pharmacokinetics (PK) profile: T1/2

    Parameters: Terminal half-life (T1/2)

    Measured: First 5 weeks after initial administration of CX1003

  4. Pharmacokinetics (PK) profile: AUC

    Parameters: Area under the plasma concentration versus time curve (AUC)

    Measured: First 5 weeks after initial administration of CX1003

  5. Pharmacokinetics (PK) profile: CL/F

    Parameters: Apparent body clearence from plasma (CL/F)

    Measured: First 5 weeks after initial administration of CX1003

  6. Pharmacokinetics (PK) profile: Vz/F

    Parameters: Apparent volume of distribution (Vz/F)

    Measured: First 5 weeks after initial administration of CX1003

  7. Objective Response Rate (ORR)

    Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.1.

    Measured: up to 24 months

  8. Progression-free survival (PFS)

    Progression-free survival (PFS) was defined as the time from the start date of study drug to the date of the first radiologically documented progressive disease (PD) per RECIST 1.1 or death due to any cause.

    Measured: up to 24 months

  9. Disease Control Rate (DCR)

    Disease Control Rate (DCR) was defined as the percentage of participants with a best overall complete response (CR), partial response (PR), or stable disease (SD) per RECIST 1.1.

    Measured: up to 24 months

  10. Duration of Response (DOR)

    Duration of response (DOR) was defined as the time from first documented response (partial response (PR) or complete response (CR)) to the date of first documented disease progression (PD) or death due to any cause, among patients with a confirmed PR or CR per RECIST 1.1.

    Measured: up to 24 months

  11. Safety profile as assessed by the incidence, duration, and severity of adverse events

    Incidence, duration, and severity of AEs measured by laboratory assessments and physical findings according to NCI CTCAE 5.0.

    Measured: From first dose of CX1003 to 30 days after last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2019
  2. Study start27 Apr 2020
  3. Primary completionOct 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04093466
Sponsor's protocol ID
KNTN-I-02
Status last verified
Oct 2024
First submitted
15 Sep 2019
Last updated
17 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CX1003 in people with Advanced Solid Tumor, run by Beijing Konruns Pharmaceutical Co., Ltd. at 1 site in China.

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 5 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: status not confirmed, as of the sponsor's last update on 17 Oct 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 China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Junyu Wu, Ph.D (0086-10-53056686 ext. 2063, wujy@konruns.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicities (DLTs) by NCI CTCAE 5.0: Dose Escalation Stage (time frame: First 5 weeks after initial administration of CX1003). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04093466.

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 17 Oct 2024.

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