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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04585035 | Study to Evaluate D-1553 in Subjects With Solid Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 180 | — | — | Oct 2, 2020 | Dec 1, 2025 | Mar 18, 2025 | 25 | United States, Australia +2 |
| Arm | Type | Description |
|---|---|---|
| Dose escalation of D-1553 monotherapy | EXPERIMENTAL | Phase 1a will evaluate up to 7 sequential cohorts with different doses of D-1553 to determine safety, tolerability, MTD and RDE in patients with solid tumors with KRasG12C mutation. |
| Dose combination of D-1553 with other therapies | EXPERIMENTAL | Phase 1b will determine the MTD of D-1553 in combination treatment in subjects with advanced or metastatic NSCLC, CRC and other solid tumors. There are multiple groups in Phase 1b for different tumor types and treatment combinations to evaluate safety, MTD and RP2D. |
| Phase 2 of D-1553 monotherapy and combination therapies | EXPERIMENTAL | The Phase 2 portion is a multi-arm, parallel, open label study to evaluate the efficacy of D- 1553 single agent and combination treatments in subjects with advanced or metastatic solid tumors with KRas G12C mutation. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose. |
| Name | Type | Description |
|---|---|---|
| D-1553 | DRUG | D-1553 is a novel, targeted KRasG12C inhibitor that is being developed as a potential oral agent for advanced or metastatic solid tumors with KRasG12C mutation. |
| D-1553 in combination with Drug: pembrolizumab, Drug:KEYTRUDA® , Drug: cetuximab, Drug: other | DRUG | Standard treatment of solid tumor, NSCLC or CRC |
Inclusion criteria * Subject with histologically proven, locally advanced, unresectable and/or metastatic solid tumor, for which no standard treatment is available, or the subject is refractory to or intolerant of existing standard treatment. * Subject has KRasG12C mutation in tumor tissue or other...