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A Study of MUC16-Directed Antibody Drug Conjugate HWK-016 in Participants With Advanced Solid Tumors.

NCT07470853 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2026-03-13

No results posted yet for this 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

Interventions

DRUG

HWK-016, MUCIN-16-targeted ADC

HWK-016 is a MUCIN-16-targeted Antibody-Drug-Conjugate (ADC) being developed for the treatment of solid tumors.

DRUG

Bevacizumab

Bevacizumab administered according to the USPI in 21-day cycles

Sponsors & Collaborators

  • Catalyst Pharmaceutical Research

    collaborator INDUSTRY

  • Whitehawk Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Margaret C Dugan, MD · Whitehawk Therapeutics

  • Edward Spindler, BS, MBA · Whitehawk Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-15
Primary Completion
2028-02-29
Completion
2028-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07470853 on ClinicalTrials.gov