All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

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).

Once the effective dose has been determined, 1\~2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.

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)

M108

Zhaoyu Jin, Ph.D

Lin Shen, PhD

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.

Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China

A Phase I, Multi-center, Open-label, Single-dose Escalation and Expansion, Dose Escalation and Expansion Combination With Chemotherapy Study Evaluating the Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China

defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)

Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies(ADA).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China	NCT04894825	Advanced Unrese...	M108 M108	18 Years - 75 Years	FutureGen Biopharmaceutical (Beijing) Co., Ltd
Safety, Tolerability and Pharmacokinetic Profile of M108 Monoclonal Antibody in Patients With Advanced Unresectable Solid Tumors in China	NCT04894825	Advanced Unrese...	M108 M108	18 Years - 75 Years	FutureGen Biopharmaceutical (Beijing) Co., Ltd

Spots Global Cancer Trial Database for m108

Every month we try and update this database with for m108 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for m108

Every month we try and update this database with for m108 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for m108 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.