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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07318649 | Phase 2 Clinical Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GH21 Capsules Combined With D-1553 Tablets in Subjects With Locally Advanced or Metastatic Solid Tumors With the KRASG12C Mutation | PHASE2 | NOT YET_RECRUITING | 120 | — | — | Dec 30, 2025 | Jun 30, 2027 | Jan 6, 2026 | 1 | China |
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
| Arm | Type | Description |
|---|---|---|
| Subjects received treatment with GH21 combined with D-1553, with 21 days as one cycle | EXPERIMENTAL | D-1553 tablet, BID, orally. Each cycle lasts 3 weeks. GH21 Capsule: QD, oral, Each treatment cycle lasts 3 weeks. |
| Name | Type | Description |
|---|---|---|
| GH21，D-1553 | DRUG | * D-1553 tablet, BID, orally. Each cycle lasts 3 weeks. * GH21 Capsule: QD, oral, Each treatment cycle lasts 3 weeks. |
Inclusion Criteria: * 1)Patients or their legal representatives can understand and voluntarily sign a written informed consent form (before starting this study and any study procedures); 2)Age ≥ 18 years, male or female; 3)Cohort 1: Histologically or cytologically confirmed locally advanced or meta...