NCT07470853RecruitingPhase 1
A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
A Phase 1 First-in-Human Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.
Source: ClinicalTrials.gov · Last updated 18 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 265 (estimated)
- First submitted
- 9 Mar 2026
- Start date
- 15 Mar 2026
- Primary completion date
- Feb 2028
- Lead sponsor
- Whitehawk Therapeutics, Inc.
- Diseases
- Endometrial cancer, Ovarian cancer
- NCT number
- NCT07470853
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 265
- From 15 Mar 2026 to the primary completion date, Feb 2028
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any serious unresolved toxicities from prior therapy
Other illness
- Individual with history of carcinomatous meningitis
- Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Individual with evidence of corneal keratopathy or history of cornea transplant
- Significant cardiovascular disease
- History of pneumonitis/interstitial lung disease
Lab values
- Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
Other
- Individual with known or suspected uncontrolled central nervous system (CNS) metastases
- Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention
Who the study is looking for
- Have one of the following solid tumor cancers:
- Monotherapy escalation, backfill and expansion cohorts:
- Endometrial Carcinoma
- Ovarian Cancer
- Combination Escalation, Backfill and Expansion Cohorts a. Ovarian Cancer
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atrium Health - Wake Forest Coordinator of this site? Confirm its status | Charlotte | United States | Not yet recruiting |
| Ohio State University Wexner Medical Center Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| SCRI - Mary Crowley Cancer Research Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Karmanos Cancer Center Coordinator of this site? Confirm its status | Detroit | United States | Not yet recruiting |
| University of Arkansas - Winthrop P. Rockefeller Cancer Institute Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Start - Ny Coordinator of this site? Confirm its status | Long Island City | United States | Recruiting |
| START - Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| St. Francis Medical Center, OSF Healthcare Coordinator of this site? Confirm its status | Peoria | United States | Recruiting |
| SCRI - Sydney Kimmel Cancer Center - Jefferson Health Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| START Mountain Coordinator of this site? Confirm its status | Salt Lake City | United States | Recruiting |
| SCRI - Florida Cancer Specialists Coordinator of this site? Confirm its status | Sarasota | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.