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M108 is a monoclonal antibody specific for gastric and gastroesophageal adenocarcinomas. The aim of this phase I study is to establish safety and Tolerability of different Dosage regimen in patients With Advanced Unresectable Solid Tumors in China.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Cohort | Experimental | Monotherapy: Five dose levels of M108 will be tested according to an accelerated titration method followed by a conventional 3 + 3 study design. Combined with chemotherapy: Three dose levels of M108 will be tested by a conventional 3 + 3 study design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (21 days). |
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| Dose Expansion Cohort | Experimental | Once the effective dose has been determined, 1~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M108 | Drug | Monotherapy: Accelerated titration method, IV infusion Q3W; Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0) | From enrollment until 28+7 days after the last dose |
| Maximum Tolerated Dose | MTD | 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum measured plasma concentration of M108 | Cmax | From enrollment until 28 days after the last dose |
| Time to maximum plasma concentration of M108 | Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaoyu Jin, Ph.D | Contact | 010-60709130 | pr@futuregenbiopharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| M108 | Drug | IV infusion Q3W. (21-day cycles) |
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| From enrollment until 28 days after the last dose |
| Half-life of M108 | T1/2 | From enrollment until 28 days after the last dose |
| Immunogenicity profile of M108 | Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA). | From enrollment until 28 days after the last dose |
| Objective Response Rate | ORR | From first dose to disease progression , death or end of study,an average of 1 year |
| Progression free survival | PFS | From first dose to disease progression , death or end of study,an average of 1 year |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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