A Study of HWK-016 for Advanced Solid Tumors
This study is testing a new treatment called HWK-016 for people with advanced solid tumors, specifically ovarian cancer and endometrial cancer. HWK-016 is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells that have a specific marker called MUCIN-16. The study is also looking at HWK-016 when given together with another drug called Bevacizumab. The main goal is to find the safest and most effective dose of HWK-016. You might be able to join if you are 18 or older and have certain types of advanced ovarian or endometrial cancer. The study is currently unclear about its recruitment status.
- Study design
- This is a Phase 1 study, meaning it's an early-stage study to find the right dose. It is an open-label study, so both you and your doctors will know which treatment you are receiving. It plans to enroll 265 participants and does not have a control group.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary goals of the study involve measurements taken during the first 21-day cycle of treatment, until the maximum tolerated dose is found.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
At a glance
Conditions
Where it's being run
12 sites across 11 statesStudy leadership
- Margaret C Dugan, MD · STUDY_DIRECTOR · Whitehawk Therapeutics
- Allison Uppalawanna · STUDY_DIRECTOR · Whitehawk Therapeutics
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
What this trial measures
- Determine Maximum Tolerated Dose (MTD)From Cycle 1, Day 1 Until Cycle 1, Day 21 (21-day cycles)
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 Maximum Administered Dose (MAD)From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
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 Recommended Dose For Expansion (RDE)From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycle) until MTD is identified.
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.