Trials / Unknown
UnknownNCT04894825
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
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 152 (estimated)
- Sponsor
- FutureGen Biopharmaceutical (Beijing) Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | M108 | 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) |
| DRUG | M108 | IV infusion Q3W. (21-day cycles) |
Timeline
- Start date
- 2021-06-11
- Primary completion
- 2024-07-30
- Completion
- 2024-12-30
- First posted
- 2021-05-20
- Last updated
- 2023-11-27
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04894825. Inclusion in this directory is not an endorsement.