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A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
NCT07470853 · View on ClinicalTrials.gov ↗
Study Summary
HWK-016-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-016, a targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors. The study employs a dose escalation and dose expansion design without a control group. The study consists of 2 parts (Part A: monotherapy and Part B: combination therapy with bevacizumab); each part has 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). Enrollment to Part A (Phase 1a and Phase 1b) will include ovarian and endometrial cancers. Enrollment to Part B (Phase 1a and Phase 1b) will include ovarian cancer only. A subsequent protocol amendment may evaluate additional tumor types.
Conditions Studied
Interventions
- DRUG Bevacizumab
- DRUG HWK-016, MUCIN-16-targeted ADC
Study Locations (12)
New York
- Start - Ny — Lake Success
- Memorial Sloan Kettering Cancer Center — New York
Arkansas
- University of Arkansas - Winthrop P. Rockefeller Cancer Institute — Little Rock
California
- START - Los Angeles — Los Angeles
Florida
- SCRI - Florida Cancer Specialists — Sarasota
Illinois
- St. Francis Medical Center (OSF Healthcare) — Peoria
Michigan
- Karmanos Cancer Center — Detroit
North Carolina
- Atrium Health - Wake Forest — Charlotte
Ohio
- Ohio State University Wexner Medical Center — Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2026-03-15 |
| Est. Completion | 2028-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07470853
The ClinicalTrials.gov registry entry for NCT07470853 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 265 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Whitehawk Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Endometrial Cancer appearing as the primary indexed condition, and to 2 interventions — of which Bevacizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07470853 reports 12 study locations spanning 11 distinct geographic areas — top geographies include New York, Arkansas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07470853 about?
NCT07470853 is a clinical study titled "A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.". HWK-016-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-016, a targeted antibody-drug conjugate (ADC) in adult participants with advanced or metastatic solid tumors. The study employs a dose escalation and dose expansion design without a control group. The study ...
What is the current status of trial NCT07470853?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 265 participants. The study started on 2026-03-15. Estimated completion is 2028-02.
What conditions does trial NCT07470853 study?
This clinical trial studies the following conditions: Endometrial Cancer, Platinum Resistant Ovarian Cancer, PROC. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07470853?
The interventions under investigation include: Bevacizumab (DRUG), HWK-016, MUCIN-16-targeted ADC (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07470853?
This trial is sponsored by Whitehawk Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07470853 being conducted?
This trial has 12 study locations across Arkansas, California, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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