Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HWK-016 · 1 trial · 3 indications
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 ...
HWK-016 is an investigational MUC16-directed antibody drug conjugate being developed by Whitehawk Therapeutics, Inc. (ticker WHWK) for advanced solid tumors, including platinum-resistant ovarian cancer (PROC), endometrial cancer, and other platinum-resistant ovarian cancer settings. It is currently in Phase 1 clinical development.
HWK-016 is being studied for use in platinum-resistant ovarian cancer (PROC) and other advanced solid tumors, including endometrial cancer. It is an investigational therapy and has not been approved for any indication. The ongoing Phase 1 trial is evaluating its use in participants with these tumor types.
HWK-016 targets MUC16, a protein expressed on certain solid tumors. As a MUC16-directed antibody drug conjugate, it is designed to deliver a therapeutic payload to cells expressing MUC16. This targeted approach is being evaluated in a Phase 1 study in advanced solid tumors.
HWK-016 is being developed by Whitehawk Therapeutics, Inc., which trades under the ticker WHWK. The company is responsible for the clinical development of this MUC16-directed antibody drug conjugate.
HWK-016 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 trial is currently recruiting participants with advanced solid tumors.
HWK-016 is being evaluated in a Phase 1 clinical trial, NCT07470853, titled "A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors." The trial is recruiting and has an estimated enrollment of 265 participants across sites in the United States.
Yes, HWK-016 is also known as a MUCIN-16-targeted ADC. Both names refer to the same investigational antibody drug conjugate developed by Whitehawk Therapeutics, Inc. (WHWK) that targets MUC16.