Fact CheckerSign in

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.
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

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Atrium Health - Wake Forest
Coordinator of this site? Confirm its status
CharlotteUnited StatesNot yet recruiting
Ohio State University Wexner Medical Center
Coordinator of this site? Confirm its status
ColumbusUnited StatesRecruiting
SCRI - Mary Crowley Cancer Research
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Karmanos Cancer Center
Coordinator of this site? Confirm its status
DetroitUnited StatesNot yet recruiting
University of Arkansas - Winthrop P. Rockefeller Cancer Institute
Coordinator of this site? Confirm its status
Little RockUnited StatesRecruiting
Start - Ny
Coordinator of this site? Confirm its status
Long Island CityUnited StatesRecruiting
START - Los Angeles
Coordinator of this site? Confirm its status
Los AngelesUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesNot yet recruiting
St. Francis Medical Center, OSF Healthcare
Coordinator of this site? Confirm its status
PeoriaUnited StatesRecruiting
SCRI - Sydney Kimmel Cancer Center - Jefferson Health
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting
START Mountain
Coordinator of this site? Confirm its status
Salt Lake CityUnited StatesRecruiting
SCRI - Florida Cancer Specialists
Coordinator of this site? Confirm its status
SarasotaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.