Study of HWK-007 for Advanced Solid Tumors
This study is testing a new drug called HWK-007 for adults with advanced solid tumors, including certain types of endometrial cancer, ovarian cancer, and non-squamous non-small cell lung cancer (NSCLC) that is EGFR wild-type (meaning it doesn't have a specific gene change). HWK-007 is an antibody drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells that have a protein called PTK7. The main goals of this study are to find the safest and most effective dose of HWK-007. To join, you must have one of the specific cancers mentioned and be at least 18 years old. This is a first-in-human study, meaning it's one of the first times this drug is being tested in people.
- Study design
- This is an open-label, first-in-human study with an estimated 226 participants. It has two phases: dose escalation to find the right dose, and dose expansion to further evaluate that dose.
- What's involved
- HWK-007 will be given as an intravenous (IV) infusion every three weeks. The study will measure safety and dose-related information during these 21-day cycles.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for determining the maximum tolerated dose and recommended dose are measured during 21-day cycles until the dose is identified. The total follow-up duration is not specified.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
At a glance
Conditions
Where it's being run
12 sites across 10 statesStudy leadership
- Margaret C Dugan, MD · STUDY_DIRECTOR · Whitehawk Therapeutics
- Allison Upalawanna · STUDY_DIRECTOR · Whitehawk Therapeutics
Who to contact
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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-007 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).
- 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 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).
- Determine the Recommended Dose for Expansion (RDE)From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.
Determine the dose that will be recommended for further study within the tumor types studied in this clinical trial 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).