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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M7824+paclitaxel | Drug | M7824 will be administered intravenously at a dose of 1200 mg every 3 weeks in combination with paclitaxel 80 (or 70) mg/m2 once a week for 3 weeks (each cycle is 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Dose-limiting toxicity in subjects with M7824 and paclitaxel combination treatment | Within first 4 weeks | |
| Phase 2: Progression-free survival in subjects with M7824 and paclitaxel combination treatment | At 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 3 months after the last dose study treatment of the last subject | |
| Objective response rate according to RECIST 1.1 | 3 months after the last dose study treatment of the last subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sun Young RHA, MD, PhD | Yonsei Cancer Center, Severance Hospital, Yonsei University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Disease control rate according to RECIST 1.1 | 3 months after the last dose study treatment of the last subject |
| Duration of response according to RECIST 1.1 | 3 months after the last dose study treatment of the last subject |
| Progression-free survival according to RECIST 1.1 | 3 months after the last dose study treatment of the last subject |
| Safety and Tolerability, in terms of the number, severity, and duration of treatment-emergent adverse events as assessed by CTCAE v5.0 | Throughout the overall trial period as well as up to 3 months after the last dose study treatment for each subject |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |