Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07507526 | A Study of Disitamab Vedotin, Tunlametinib, and PD-1 Antibody for Advanced Gastric Cancer | PHASE2 | NOT YET_RECRUITING | 76 | — | — | Apr 1, 2026 | Apr 30, 2028 | Apr 2, 2026 | 1 | China |
Objective response rate is defined as the proportion of participants who achieve a best overall response of either complete response (CR) or partial response (PR) according to irRECIST (immune-related Response Evaluation Criteria in Solid Tumors) criteria.
| Arm | Type | Description |
|---|---|---|
| DTP | EXPERIMENTAL | Disitamab vedotin (RC48): 2.5 mg/kg intravenously on Day 1 of each 14-day cycle Tislelizumab: 400 mg intravenously on Day 1 of each 42-day cycle Tunlametinib: Orally every 12 hours at the dose determined during the safety run-in phase |
| Name | Type | Description |
|---|---|---|
| Tunlametinib+PD-1 mAb | DRUG | Disitamab vedotin (RC48): 2.5 mg/kg intravenously on Day 1 of each 14-day cycle Tislelizumab: 400 mg intravenously on Day 1 of each 42-day cycle Tunlametinib: Orally every 12 hours at the dose determined during the safety run-in phase |
Inclusion Criteria: Patients with advanced gastric cancer who have received at least two lines of prior systemic therapy or are intolerant to standard therapy; HER2 immunohistochemistry (IHC) 2+ or 3+; Presence of measurable target lesions according to irRECIST criteria; Expected survival of at lea...