Gastric CancerPhase 2NCT05395780
A Phase 2 Study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With Advanced Gastric Cancer or Gastroesophageal Junction Cancer
A Phase 2 study testing MAX-40279 in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Maxinovel Pty., Ltd. at 1 site in China.
Trial summary
This is a single-arm, multi-center phase II clinical study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With advanced gastric cancer or gastroesophageal junction cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- What is being tested?
- MAX-40279
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jun 2022to Dec 2023
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary participation in the clinical study; full understanding of and fully informed of the study and signing of the informed consent form (ICF); being willing to follow and able to complete all trial procedures.
- Age ≥ 18 years and ≤ 80 years, male or female.
- Patients with histologically or cytologically confirmed advanced gastric adenocarcinoma (GC) or gastroesophageal junction (GEJ) adenocarcinoma on the second or later lines of treatment who failed at least the first line of standard treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 point.
- Presence of measurable lesions meeting RECIST 1.1 criteria.
- Expected survival ≥ 12 weeks.
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- Before administration, patients must provide 5-8 unstained tumor tissue slides (samples taken within 12 months before the first dose) or fresh tissue specimens of ≥ 2 mm3.
- Adequate organ and bone marrow functions as defined below (no treatment with blood transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) within 14 days before the first dose of the investigational drug).
- The interval between the first dose of the investigational drug and previous major surgery, treatment with medical devices, or local radiotherapy (excluding palliative radiotherapy) should be at least 28 days; that for previous cytotoxic chemotherapy, endocrinotherapy, or treatment with biologicals should be at least 21 days; that for previous hormonotherapy or minor surgery should be at least 14 days; that for treatment with small-molecule targeted drugs should be at least 14 days or 5 half-lives, whichever is longer;
- Female patients of childbearing age must undergo a serum pregnancy test within 7 days before administration of the investigational drug and the results should be negative, and they should be willing to take medically accepted, effective contraceptive measures (e.g., intrauterine device, contraceptives, or condoms) during the study period and within 3 months after the last dose of the investigational drug; male patients with female partners of childbearing age should have been surgically sterilized, or agree to implement effective contraceptive measures during the study period and within 3 months after the last dose of the investigational drug.
Who cannot join
- Those who were diagnosed of any other malignancies within 3 years before the first dose, except for basal cell or squamous cell skin cancer or carcinoma in situ that has been adequately treated.
- Known allergy to the investigational drug or any of its excipients.
- Those with known Her-2 positive gastric adenocarcinoma or GEJ adenocarcinoma receiving no previous treatment of the target (e.g., Herceptin®) (those with PD can be enrolled after treatment with Herceptin®).
- Known and uncontrolled or symptomatic active central nervous system (CNS) metastasis manifested as clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth. History of CNS metastases or spinal cord compression; those who received definite treatment and showed stable clinical manifestations after 4-week discontinuation of anticonvulsants and steroids before the first dose of the investigational drug can be enrolled in the study.
- Any previous treatment-induced toxicity that has not been relieved to normal or grade ≤ 1 (NCI CTCAE v5.0) before the first dose (except for alopecia, grade ≤ 2 fatigue, poor appetite, and peripheral neurotoxicity).
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HbsAg positive or HbcAb positive and HBV DNA is greater than ULN), hepatitis C (hepatitis C antibodies are positive, and HCV-RNA is greater than the lower limit of detection for analytical method), or coinfection of hepatitis B and hepatitis C.
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- Those with serious comorbidities, including but not limited to: uncontrollable active infections, active peptic ulcers, and decompensated respiratory disorders.
- Those who have clinical symptoms or signs of gastrointestinal tract obstruction before the first dose and require parenteral fluid replacement or nutrition. Patients with inflammatory bowel diseases or chronic diarrhea. Patients who underwent total gastrectomy.
- Presence of following conditions within 6 months before the first dose: myocardial infarction, serious/unstable angina, NYHA class > II cardiac insufficiency, poorly controlled arrhythmia (including QTcF intervals of > 450 ms for males and > 470 ms for females, by Fridericia's formula), or symptomatic congestive cardiac failure.
- Hypertension that cannot be effectively controlled by antihypertensive drugs (systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).
- Known hereditary or acquired hemorrhage and thrombophilia, such as hemophilia, coagulopathy, thrombocytopenia, and hypersplenism.
- Presence of significant hemoptysis or daily hemoptysis of up to half a teaspoon (2.5 mL) or more within 2 months before the first dose.
- Presence of clinically significant hemorrhage symptoms (e.g., hemorrhage of digestive tract) or hemorrhagic tendency within 3 months before the first dose, or vasculitis.
- Presence of arterial/venous thromboembolic events within 6 months before the first dose, such as cerebrovascular accident (including transient ischemic stroke, cerebral hemorrhage, and cerebral infarction), deep venous thromboembolism, and pulmonary embolism.
- Those requiring long-term anticoagulant therapy with warfarin or heparin or long-term antiplatelet therapy (aspirin ≥ 300 mg/d or clopidogrel ≥ 75 mg/d) during the study period.
- Pregnant and breastfeeding patients.
- Patients with other serious physical or mental diseases or laboratory test abnormalities that may increase the risks for participation in the study or interference with the study results, and patients who are deemed unsuitable to participate in the study as assessed by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jingsu, 210000
Jia Wei, 025-68182923, weijia01627@hotmail.com
About this study
Official title: An Open-label, Multi-center Phase II Clinical Study on MAX-40279-01 as Second or Later Lines of Treatment of Advanced Gastric Cancer or Gastroesophageal Junction Cancer
This is a single-arm, multi-center phase II clinical study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With advanced gastric cancer or gastroesophageal junction cancer.
Read the detailed description
This is a single-arm, multi-center phase II clinical study.
This study intends to enroll 20-30 subjects with advanced GC or GEJ adenocarcinoma on second or later lines of treatment (the tumor tissues of ≥ 50% of subjects will be tested by RNAseq, with FGOP2 TPM ≥ 9). Subjects will be randomly assigned to cohort 1 or 2 in a 1:1 ratio:
Cohort 1: High-dose MAX-40279 group (10-15 subjects, 70 mg, BID, PO) Cohort 2: Low-dose MAX-40279 group (10-15 subjects, 50 mg, BID, PO)
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Being tested
- MAX-40279
- Keywords
- Advanced/ gastric cancer/ gastroesophageal junction cancer.
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAX-40279Drug
Also called MAX-40279-01 capsule
MAX-40279 capsule will be administered orally
| Study group | Role | What they receive |
|---|---|---|
| High-dose MAX-40279 group | Experimental | High-dose MAX-40279 capsule group (10-15 subjects, 70 mg, BID, PO) Receives: Drug: MAX-40279 |
| Low-dose MAX-40279 group | Experimental | Low-dose MAX-40279 capsule group (10-15 subjects, 50 mg, BID, PO) Receives: Drug: MAX-40279 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: Through study completion, an average of 1 year
Secondary outcomes (9)
Progression free survival (PFS)
Measured: Through study completion, an average of 1 year
Duration of response (DoR)
Measured: Through study completion, an average of 1 year
Disease control rate (DCR)
Measured: Through study completion, an average of 1 year
Overall survival (OS)
Measured: Through study completion, an average of 1 year
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) and abnormalities in vital signs,electrocardiogram (ECG), and laboratory tests
Measured: Through study completion, an average of 1 year
Cmax
Maximum plasma drug concentration of Max-40279
Measured: Through study completion, an average of 1 year
Tmax
Time to maximum plasma concentration of Max-40279 Time to maximum plasma concentration of Max-40279 Time to maximum plasma concentration of Max-40279 Time to maximum plasma concentration of Max-40279
Measured: Through study completion, an average of 1 year
AUC
Area under the time-concentration curve of Max-40279
Measured: Through study completion, an average of 1 year
Correlation between expression level and mutation of FGFR1OP2-related proteins and efficacy
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study startJun 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxinovel Pty., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395780
- Sponsor's protocol ID
- MAX-40279-006
- Status last verified
- Nov 2021
- First submitted
- 19 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Phase II Clinical Study on MAX-40279-01 as Second or Later Lines of Treatment of Advanced Gastric Cancer or Gastroesophageal Junction Cancer
- ClinicalTrials.gov ID
- NCT05395780
- Acronym / sponsor ID
- MAX-40279-006
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Keywords
- Advanced/ gastric cancer/ gastroesophageal junction cancer.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Maxinovel Pty., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 May 2022 (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.
This is a single-arm, multi-center phase II clinical study to Evaluate the Safety and Efficacy of Max-40279-01 in Patients With advanced gastric cancer or gastroesophageal junction cancer.
Detailed description
This is a single-arm, multi-center phase II clinical study.
This study intends to enroll 20-30 subjects with advanced GC or GEJ adenocarcinoma on second or later lines of treatment (the tumor tissues of ≥ 50% of subjects will be tested by RNAseq, with FGOP2 TPM ≥ 9). Subjects will be randomly assigned to cohort 1 or 2 in a 1:1 ratio:
Cohort 1: High-dose MAX-40279 group (10-15 subjects, 70 mg, BID, PO) Cohort 2: Low-dose MAX-40279 group (10-15 subjects, 50 mg, BID, PO)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose MAX-40279 group | Experimental | Drug: MAX-40279High-dose MAX-40279 capsule group (10-15 subjects, 70 mg, BID, PO) |
| Low-dose MAX-40279 group | Experimental | Drug: MAX-40279Low-dose MAX-40279 capsule group (10-15 subjects, 50 mg, BID, PO) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntary participation in the clinical study; full understanding of and fully informed of the study and signing of the informed consent form (ICF); being willing to follow and able to complete all trial procedures.
- Age ≥ 18 years and ≤ 80 years, male or female.
- Patients with histologically or cytologically confirmed advanced gastric adenocarcinoma (GC) or gastroesophageal junction (GEJ) adenocarcinoma on the second or later lines of treatment who failed at least the first line of standard treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 point.
- Presence of measurable lesions meeting RECIST 1.1 criteria.
Key exclusion criteria (17 listed)
- Those who were diagnosed of any other malignancies within 3 years before the first dose, except for basal cell or squamous cell skin cancer or carcinoma in situ that has been adequately treated.
- Known allergy to the investigational drug or any of its excipients.
- Those with known Her-2 positive gastric adenocarcinoma or GEJ adenocarcinoma receiving no previous treatment of the target (e.g., Herceptin®) (those with PD can be enrolled after treatment with Herceptin®).
- Known and uncontrolled or symptomatic active central nervous system (CNS) metastasis manifested as clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth. History of CNS metastases or spinal cord compression; those who received definite treatment and showed stable clinical manifestations after 4-week discontinuation of anticonvulsants and steroids before the first dose of the investigational drug can be enrolled in the study.
- Any previous treatment-induced toxicity that has not been relieved to normal or grade ≤ 1 (NCI CTCAE v5.0) before the first dose (except for alopecia, grade ≤ 2 fatigue, poor appetite, and peripheral neurotoxicity).
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 |
|---|---|---|
| MAX-40279Also: MAX-40279-01 capsuleMAX-40279 capsule will be administered orally | Drug | High-dose MAX-40279 group, Low-dose MAX-40279 group |
Primary outcome
Objective response rate (ORR)
Time frame: Through study completion, an average of 1 year
9 secondary outcomes
Progression free survival (PFS)
Time frame: Through study completion, an average of 1 year
Duration of response (DoR)
Time frame: Through study completion, an average of 1 year
Disease control rate (DCR)
Time frame: Through study completion, an average of 1 year
Overall survival (OS)
Time frame: Through study completion, an average of 1 year
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) and abnormalities in vital signs,electrocardiogram (ECG), and laboratory tests
Time frame: Through study completion, an average of 1 year
Cmax
Time frame: Through study completion, an average of 1 year
Tmax
Time frame: Through study completion, an average of 1 year
AUC
Time frame: Through study completion, an average of 1 year
Correlation between expression level and mutation of FGFR1OP2-related proteins and efficacy
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MAX-40279 in people with Gastric Cancer and Gastroesophageal Junction Cancer, run by Maxinovel Pty., 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 10 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: status not confirmed, as of the sponsor's last update on 2 Jun 2022. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hanying Bao, MD,Ph.D (+86-021-51370693, hybao@maxinovel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Through study completion, an average of 1 year). 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 2 Jun 2022.