drugset / Trial / NCT04835896
Study of M7824 and Paclitaxel Combination as a Second-line Treatment in Patients With Recurrent/Metastatic Gastric Cancer
NaSequentialOpen-labelTreatment
Summary
This is a Phase 1b/2 study to identify the recommended dose of M7824 for further study with weekly paclitaxel, and to assess the safety and clinical efficacy of this combined treatment in advanced gastric cancer after first line treatment. The study will be conducted in two parts: Part 1 (Phase 1b) dose escalation study to determine the MTD and RP2D of weekly paclitaxel in combination with fixed dose M7824, Part 2 (Phase 2) to further evaluate the safety and tolerability of the combination of M7824 and paclitaxel at the RP2D and determine anti-tumor activity.
Timeline
- Start
- 2021-06-02
- Primary completion
- 2023-10-27
- Completion
- 2023-10-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bintrafusp alfa | Protein / enzyme biologic | 1200 mg | Intravenous |
| Subject | Paclitaxel | Small molecule | 70 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 80 mg/m2 | — |
Indications
No indication recorded.