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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07470853 | A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors. | PHASE1 | RECRUITING | 265 | — | — | Mar 15, 2026 | Feb 1, 2028 | Mar 13, 2026 | 12 | United States |
Determine the highest dose of HWK-016 that can be administered without signs of toxicity, measured at the end of Cycle 1(21-day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer
Determine the highest dose of HWK-016 administered during the dose escalation part of the study, measured at the end of Cycle 1 (21-day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer
Determine the dose of HWK-016 that will be recommended for further study within the tumor types studied in this clinical trial, measured at the end of Cycle 1, Day 21 (21-day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE). Evaluate the safety and tolerability of HWK-016 at the selected RDE(s) determined from Phase 1a, as monotherapy (Part A) in participants with ovarian and endometrial cancers and in combination therapy with bevacizumab (Part B) in participants with ovarian cancer.
| Arm | Type | Description |
|---|---|---|
| Part A - Dose Escalation - 21 Day treatment cycles | EXPERIMENTAL | Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) |
| Part A - Dose Expansion Group 1 - 21-day treatment cycle - Tumor TBD | EXPERIMENTAL | Dose Optimization of Recommended dose for expansion 1 |
| Part A - Dose Expansion Group 2 - 21-day treatment cycle - Tumor TBD | EXPERIMENTAL | Expanded enrolment at Recommended Dose for Expansion 2 in Ovarian Cancer |
| Part A - Dose Expansion Group 3 - 21-day treatment cycle - Tumor TBD | EXPERIMENTAL | Expansion of enrolment at RDE 1 or 2 in Tumor TBD |
| Part B - Dose Escalation - 21 Day treatment cycles of HWK-016 in combination with Bevacizumab | EXPERIMENTAL | Escalating doses of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer |
| Part A - Dose Expansion Group 4 - 21-day treatment cycle - Tumor TBD | EXPERIMENTAL | Expansion of enrolment at RDE 1 or 2 in Tumor TBD |
| Part B - Dose Expansion Cohort 1- 21 Day cycles of HWK-016 in combination with Bevacizumab | EXPERIMENTAL | Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Ovarian cancer |
| Part B - Dose Expansion Cohort 2 - 21 Day cycles of HWK-016 in combination with Bevacizumab | EXPERIMENTAL | Expanded enrolment at RDE of HWK-016, a MUCIN-16-targeted ADC administered intravenously (IV) combined with Bevacizumab (IV) in Tumor TBD |
| Name | Type | Description |
|---|---|---|
| HWK-016, MUCIN-16-targeted ADC | DRUG | HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors. |
| Bevacizumab | DRUG | Bevacizumab administered according to the USPI in 21-day cycles |
Inclusion Criteria: * Have one of the following solid tumor cancers: 1. Monotherapy escalation, backfill and expansion cohorts: 1. Endometrial Carcinoma 2. Ovarian Cancer 2. Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer Exclusion Criteria: 1. Individual ...