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HWK-016, MUCIN-16-targeted ADC · 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 antibody drug conjugate being studied for the treatment of advanced solid tumors, including platinum-resistant ovarian cancer (PROC) and endometrial cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
HWK-016 targets MUCIN-16, also known as MUC16, a protein that is often overexpressed in certain cancers. As an antibody drug conjugate, it is designed to deliver a cytotoxic agent to cells expressing MUC16, potentially reducing damage to healthy tissues.
HWK-016 is being developed by Whitehawk Therapeutics, Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol WHWK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
HWK-016 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary activity.
HWK-016 is being evaluated in a single Phase 1 clinical trial with the identifier NCT07470853. This study is recruiting participants with advanced solid tumors, including platinum-resistant ovarian cancer and endometrial cancer, and is being conducted in the United States with an estimated enrollment of 265 participants.
Yes, HWK-016 is a MUC16-directed antibody drug conjugate (ADC). It is designed to target the MUC16 protein, which is expressed on the surface of certain tumor cells. The drug is being studied for its potential to treat cancers that express this protein.