Advanced Solid TumorsPhase 1NCT05731934
The Tolerability and Pharmacokinetics of HX301 Monolactate Capsules in Patients With Advanced Solid Tumors
A Phase 1 study testing HX301 in people with Advanced Solid Tumors, run by Hangzhou Hanx Biopharmaceuticals, Ltd. at 1 site in China.
Trial summary
Open label, single- and multiple-dose administration, dose-exploratory clinical phase I study to evaluate the safety, tolerability and PK profile of HX301 monolactate capsules in patients with advanced malignant solid tumors and to preliminarily evaluate its antitumor efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HX301
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2020to 12 Jan 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Voluntarily agree to sign informed consent, understand the study and is willing and able to comply with all the trial procedures.
- 2) Male or female subject aged 18-75 years (including the boundary value). 3) Patients with cytologically or histopathological confirmed advanced malignant solid tumors that is refractory/relapsed to standard therapy (with disease progression or intolerance) or lack of effective treatment, or the subject refuses standard therapy.
- 4) Eastern Cooperative Oncology Group performance status of 0 to 1. 5) Life expectancy at least 3 months. 6) Subjects with measurable lesions (at least 1 extracranial lesion) according to the solid tumor evaluation criteria (RECIST v1.1).
- 7) For subjects who have received prior anti-tumor therapy, as follows:
- Systemic radiotherapy ≥ 3 weeks before the first dose, local radiotherapy to bone metastasis ≥ 2 weeks prior to the first administration of study treatment.
- Previous chemotherapy, immunotherapy (PD-1 antibody, PD-L1 antibody or CTLA-4 antibody, etc.), biological anti-tumor therapy (tumor vaccine, cytokines or growth factors), and targeted therapy ≥ 4 weeks before the first dose (small molecule targeted therapy ≥ 2 weeks prior to the first dose).
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- Previously received anti-tumor herbal medicine or medications which content herbal ingredient approved for anticancer, with an interval of ≥ 2 weeks prior to the first dose.
- 8) Subjects may have a history of brain/meningeal metastases, provided they have received local treatment (including surgery and radiotherapy, etc.) and have been stable for at least 3 months prior to the first dose.
- 9) Adequate organ and bone marrow hematopoietic function, as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1.5×109/L.
- absolute white blood cell count (WBC) ≥ 3.0×109/L.
- Platelet count ≥ 100×109/L.
- Hemoglobin ≥ 90 g/L (not treated with blood transfusion within 2 weeks before the first dose)
- Serum creatinine ≤ 1.5 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min (calculated according to the Cockcroft-Gault formula, see Annex 6)
- Serum total bilirubin (TBIL) ≤1.5 x upper limit of normal (ULN).
- AST and ALT ≤ 2.5 x ULN, and ≤ 5 x ULN in subject with liver cancer or liver metastases.
- International normalized ratio (INR) ≤ 2 x ULN or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN (unless the subject is on anticoagulation therapy, then as long as the PT or APTT is within the expected therapeutic range for anticoagulant use).
- 10) Male subjects and female subjects of childbearing potential should agree to use effective contraception from the time they sign the informed consent until 3 months after the last dose.
Who cannot join
- Subjects are excluded from the study if any of the following criteria apply:
- Patients with other malignant tumors within 5 years before enrollment, except cured cervical carcinoma in situ and cured cutaneous basal cell carcinoma.
- Failure to recover from previously treated adverse reactions to CTCAE 5.0 grade ≤ 1, except for residual alopecia effects.
- previous use or ongoing use of antitumor agents targeting CDK4/6
- inability to swallow, chronic diarrhea and intestinal obstruction with multiple factors affecting drug uptake and absorption
- Planning major surgery (excluding diagnostic surgical procedures) during this study including the 28-day screening period
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- The presence of uncorrectable hypokalemia and hypomagnesemia found to remain during the screening period.
- Presence of third interstitial fluid that cannot be controlled by drainage or other means (e.g., massive pleural fluid, ascites, pelvic effusion).
- uncontrolled and stable systemic diseases, such as severe hypertension, diabetes mellitus, thyroid disease, etc.
- unstable angina pectoris, myocardial infarction, or heart failure within 3 months prior to the first dose of the drug; a history of a heart rate disorder requiring drug treatment or considered clinically significant by the investigator; any other cardiac disease considered by the investigator to be inappropriate for participation in this trial, etc.; and cardiac function abnormalities of ≥ grade II severity (according to NYHA classification, see Annex 7) found during the screening period examination.
- History of infection with human immunodeficiency virus, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation, or history of stem cell transplantation.
- Patients with active chronic hepatitis B or active hepatitis C or active syphilis, hepatitis B virus carriers, patients with stable hepatitis B after drug treatment (DNA titer < 500 IU/mL or DNA copy number <103 copies/mL), cured hepatitis C patients (HCV RNA test negative) and cured syphilis patients (syphilis antigen negative ) can be enrolled.
- Those with severe infections within 4 weeks before the first dose.
- Participation in other drug clinical trials within 4 weeks prior to the first dose.
- Patients with a clear history of neurological or psychiatric disorders, such as epilepsy, dementia, and poor compliance.
- Female subject who is pregnant or lactating.
- Subjects who, per the opinion of the investigator, are not suitable for participation in this trial for other reasons.
Trial locations and contacts
1 site in 1 country.
China1 site
National center/cancer hospital,chinese Academy of Medical Sciences and Peking Union Medicial College
Beijing, Beijing Municipality
About this study
Official title: A Phase I Clinical Trial of the Tolerability and Pharmacokinetics of HX301 Monolactate Capsules in Patients With Advanced Solid Tumors
Open label, single- and multiple-dose administration, dose-exploratory clinical phase I study to evaluate the safety, tolerability and PK profile of HX301 monolactate capsules in patients with advanced malignant solid tumors and to preliminarily evaluate its antitumor efficacy.
Read the detailed description
The study is divided into a screening period (28 days before first dose), treatment period, and follow-up period.
In the dose escalation stage, the study will follow a 3+3 dose-escalation scheme enrolling cohorts of at least 3 subjects sequentially at escalating doses. The dose escalation phase includes a single-dose phase and a multiple-dose phase. Subjects in the single-dose phase were treated with HX301monolactate, taken orally before breakfast, and in the multiple-dose phase, the frequency of administration was once daily (QD), 3 weeks continuously, suspended for 1 week, and every 4 weeks (28 days) was a dosing cycle. Dose escalation will continue until identification of an MTD or the maximum dose is reached. Dose-limiting toxicities (DLTs) will be assessed from the first dose of study treatment until 28 days. Blood samples will be collected at regular intervals for pharmacokinetics (PK).
The Tumor evaluation (assessed by the Investigator in accordance with Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1] to assess efficacy will start from the first dose and occur every 8 weeks in the first 24 weeks and every 12 weeks thereafter.
After 1 year of treatment, if the sponsor and investigator determine that the subject can still benefit from treatment with HX301, the treatment may continue until the disease progresses, the investigator determines that the subject is no longer suitable for further treatment, the subject voluntarily withdraws from the treatment, or the sponsor withdraws the trial.
- Conditions
- Advanced Solid Tumors
- Being tested
- HX301
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HX301Drug
Also called HX301 Monolactate Capsules
At starting dose of 40 mg, followed by 4 dose levels of 80 mg, 120 mg, 160 mg, and 200 mg
| Study group | Role | What they receive |
|---|---|---|
| HX301 | Experimental | Study treatment: during each cycle (28 days), HX301 is dosed QD for 3 weeks (21 days) followed by 1 week (7 days) off therapy. Receives: Drug: HX301 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AE) in HX301 Monolactate Capsules in patients with advanced solid tumors
Adverse events (AEs) determined by the investigator are recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0).
Measured: Collected adverse events from first dosing through at least 30 days after the end of treatment, or until other cancer treatment regimens have been started (whichever occurs earlier)
Incidence of Dose Limiting Toxicities (DLT) in HX301 Monolactate Capsules in patients with advanced solid tumors
Incidence of Dose Limiting Toxicities (DLT) that would result in stopping dosing
Measured: 7 days after single dose (C0D1-C0D7) and 4 weeks after first dose of multiple dose (C1D1-C1D28).
Secondary outcomes (7)
Pharmacokinetics (PK): Maximum plasma concentration of drug (Cmax)
Highest concentration of drug measured in the PK samples
Measured: Single dose : Cycle 0 Day 1 and multiple dose : Cycle 1 Day 1,Cycle 1 Day 8,Cycle 1 Day 9,Cycle 1 Day 15 (each cycle is 28 days)
Pharmacokinetics(PK): Time to reach Cmax (Tmax)
Time from dosing until collection of the PK samples with the highest drug concentration.
Measured: Single dose : Cycle 0 Day 1 and multiple dose : Cycle 1 Day 1,Cycle 1 Day 8,Cycle 1 Day 9,Cycle 1 Day 15 (each cycle is 28 days)
Terminal Half-life （t½）of HX301
Terminal phase elimination half-life
Measured: Single dose : Cycle 0 Day 1 and multiple dose : Cycle 1 Day 1,Cycle 1 Day 8,Cycle 1 Day 9,Cycle 1 Day 15 (each cycle is 28 days)
Area Under the Serum Concentration-time Curve (AUC)
The area under the serum concentration-time curve .
Measured: Single dose : Cycle 0 Day 1 and multiple dose : Cycle 1 Day 1,Cycle 1 Day 8,Cycle 1 Day 9,Cycle 1 Day 15 (each cycle is 28 days)
Objective response rate (ORR) of HX301 Monolactate Capsules in patients with solid tumors
The ORR is defined as the percentage of participants in the analysis population who had a confirmed Complete Response or Partial Response.
Measured: Approximately 1 years
Duration of response (DoR) of HX301 Monolactate Capsules in patients with solid tumors
The DoR is defined as the time from the first recorded response (CR or PR) to the first recorded tumor progression or death due to any cause.
Measured: Approximately 1 years
Progression-free survival (PFS) of patients with solid tumors treated with HX301
The PFS is defined as the time from the start of the first dose to the first documented disease progression or death of any cause.
Measured: Approximately 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start15 Sep 2020
- Primary completion12 Jan 2024
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731934
- Sponsor's protocol ID
- HX301-I-01
- Status last verified
- Jun 2024
- First submitted
- 29 Jan 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial of the Tolerability and Pharmacokinetics of HX301 Monolactate Capsules in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05731934
- Acronym / sponsor ID
- HX301-I-01
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hangzhou Hanx Biopharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 16 Feb 2023 (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.
Open label, single- and multiple-dose administration, dose-exploratory clinical phase I study to evaluate the safety, tolerability and PK profile of HX301 monolactate capsules in patients with advanced malignant solid tumors and to preliminarily evaluate its antitumor efficacy.
Detailed description
The study is divided into a screening period (28 days before first dose), treatment period, and follow-up period.
In the dose escalation stage, the study will follow a 3+3 dose-escalation scheme enrolling cohorts of at least 3 subjects sequentially at escalating doses. The dose escalation phase includes a single-dose phase and a multiple-dose phase. Subjects in the single-dose phase were treated with HX301monolactate, taken orally before breakfast, and in the multiple-dose phase, the frequency of administration was once daily (QD), 3 weeks continuously, suspended for 1 week, and every 4 weeks (28 days) was a dosing cycle. Dose escalation will continue until identification of an MTD or the maximum dose is reached. Dose-limiting toxicities (DLTs) will be assessed from the first dose of study treatment until 28 days. Blood samples will be collected at regular intervals for pharmacokinetics (PK).
The Tumor evaluation (assessed by the Investigator in accordance with Response Evaluation Criteria in Solid Tumors Version 1.1 [RECIST 1.1] to assess efficacy will start from the first dose and occur every 8 weeks in the first 24 weeks and every 12 weeks thereafter.
After 1 year of treatment, if the sponsor and investigator determine that the subject can still benefit from treatment with HX301, the treatment may continue until the disease progresses, the investigator determines that the subject is no longer suitable for further treatment, the subject voluntarily withdraws from the treatment, or the sponsor withdraws the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HX301 | Experimental | Drug: HX301Study treatment: during each cycle (28 days), HX301 is dosed QD for 3 weeks (21 days) followed by 1 week (7 days) off therapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 1) Voluntarily agree to sign informed consent, understand the study and is willing and able to comply with all the trial procedures.
- 2) Male or female subject aged 18-75 years (including the boundary value). 3) Patients with cytologically or histopathological confirmed advanced malignant solid tumors that is refractory/relapsed to standard therapy (with disease progression or intolerance) or lack of effective treatment, or the subject refuses standard therapy.
- 4) Eastern Cooperative Oncology Group performance status of 0 to 1. 5) Life expectancy at least 3 months. 6) Subjects with measurable lesions (at least 1 extracranial lesion) according to the solid tumor evaluation criteria (RECIST v1.1).
- 8) Subjects may have a history of brain/meningeal metastases, provided they have received local treatment (including surgery and radiotherapy, etc.) and have been stable for at least 3 months prior to the first dose.
- Absolute neutrophil count (ANC) ≥ 1.5×109/L.
Key exclusion criteria (17 listed)
- Subjects are excluded from the study if any of the following criteria apply:
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 |
|---|---|---|
| HX301Also: HX301 Monolactate CapsulesAt starting dose of 40 mg, followed by 4 dose levels of 80 mg, 120 mg, 160 mg, and 200 mg | Drug | HX301 |
Primary outcome
Incidence of adverse events (AE) in HX301 Monolactate Capsules in patients with advanced solid tumors
Time frame: Collected adverse events from first dosing through at least 30 days after the end of treatment, or until other cancer treatment regimens have been started (whichever occurs earlier)
Adverse events (AEs) determined by the investigator are recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE - Version 5.0).
Incidence of Dose Limiting Toxicities (DLT) in HX301 Monolactate Capsules in patients with advanced solid tumors
Time frame: 7 days after single dose (C0D1-C0D7) and 4 weeks after first dose of multiple dose (C1D1-C1D28).
Incidence of Dose Limiting Toxicities (DLT) that would result in stopping dosing
7 secondary outcomes
Pharmacokinetics (PK): Maximum plasma concentration of drug (Cmax)
Time frame: Single dose : Cycle 0 Day 1 and multiple dose : Cycle 1 Day 1,Cycle 1 Day 8,Cycle 1 Day 9,Cycle 1 Day 15 (each cycle is 28 days)
Pharmacokinetics(PK): Time to reach Cmax (Tmax)
Time frame: Single dose : Cycle 0 Day 1 and multiple dose : Cycle 1 Day 1,Cycle 1 Day 8,Cycle 1 Day 9,Cycle 1 Day 15 (each cycle is 28 days)
Terminal Half-life （t½）of HX301
Time frame: Single dose : Cycle 0 Day 1 and multiple dose : Cycle 1 Day 1,Cycle 1 Day 8,Cycle 1 Day 9,Cycle 1 Day 15 (each cycle is 28 days)
Area Under the Serum Concentration-time Curve (AUC)
Time frame: Single dose : Cycle 0 Day 1 and multiple dose : Cycle 1 Day 1,Cycle 1 Day 8,Cycle 1 Day 9,Cycle 1 Day 15 (each cycle is 28 days)
Objective response rate (ORR) of HX301 Monolactate Capsules in patients with solid tumors
Time frame: Approximately 1 years
Duration of response (DoR) of HX301 Monolactate Capsules in patients with solid tumors
Time frame: Approximately 1 years
Progression-free survival (PFS) of patients with solid tumors treated with HX301
Time frame: Approximately 1 years
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 18 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 HX301 in people with Advanced Solid Tumors, run by Hangzhou Hanx Biopharmaceuticals, 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 18 inclusion and 17 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 18 Jun 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?
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?
Incidence of adverse events (AE) in HX301 Monolactate Capsules in patients with advanced solid tumors (time frame: Collected adverse events from first dosing through at least 30 days after the end of treatment, or until other cancer treatment regimens have been started (whichever occurs earlier)). 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?
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 18 Jun 2024.