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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05761951 | Phase 2 Study Evaluating the Efficacy of the Combination of DKN-01 (DKK1 Inhibitor, Leap Therapeutics) and Pembrolizumab in the Treatment of Advanced or Recurrent Endometrial Cancer | PHASE2 | ACTIVE NOT_RECRUITING | 8 | — | — | Aug 29, 2023 | Jan 31, 2029 | May 19, 2026 | 1 | United States |
| NCT03395080 | A Study of DKN-01 as a Monotherapy or in Combination With Paclitaxel in Patients With Recurrent Epithelial Endometrial or Epithelial Ovarian Cancer or Carcinosarcoma | PHASE2 | COMPLETED | 111 | — | — | Mar 5, 2018 | Jan 27, 2021 | Aug 1, 2025 | 17 | United States |
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
Best overall response of Complete Response (CR; disappearance of all target lesions, any pathological lymph nodes whether target or non-target must have reduction in short axis to \<10mm) or Partial Response (PR; at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters) as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1)
| Arm | Type | Description |
|---|---|---|
| DKN-01 | EXPERIMENTAL | Participants will receive DKN-01 by vein over about 30 minutes to 2 hours on Day 1 of each cycle, as well ason Day 15 of Cycle 1. |
| Pembrolizumab | EXPERIMENTAL | Participants will receive pembrolizumab by vein over about 30 minutes on Day 1 of each cycle for up to 24 months. |
| DKN-01 monotherapy in recurrent EEC | EXPERIMENTAL | 300mg DKN-01 monotherapy in recurrent EEC |
| DKN-01+paclitaxel in recurrent EEC | EXPERIMENTAL | 300mg DKN-01+paclitaxel in recurrent EEC |
| DKN-01 monotherapy in recurrent EOC | EXPERIMENTAL | 300mg DKN-01 monotherapy in recurrent EOC |
| DKN-01+paclitaxel in recurrent EOC | EXPERIMENTAL | 300mg DKN-01+paclitaxel in recurrent EOC |
| DKN-01 monotherapy in carcinosarcoma | EXPERIMENTAL | 600mg DKN-01 monotherapy in carcinosarcoma |
| DKN-01 +paclitaxel in carcinosarcoma | EXPERIMENTAL | 600mg DKN-01 +paclitaxel in carcinosarcoma |
| Name | Type | Description |
|---|---|---|
| DKN-01 | DRUG | Given by IV (vein) |
| Pembrolizumab | DRUG | Given by IV (vein) |
| Paclitaxel | DRUG | Administered by IV infusion |
| 300mg DKN-01 | DRUG | Administered by IV infusion |
| 600mg DKN-01 | DRUG | Administered by IV infusion |
Inclusion Criteria: 1. Written informed consent and any locally-required authorization (e.g., HIPAA in the USA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. 2. Female participants age ≥ 18 years at the time of signing informed conse...