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Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors

RecruitingPhase 1

A Phase 1 First-in-Human Study of PTK7-Directed Antibody Drug Conjugate HWK-007 in Participants With Advanced Solid Tumors

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

Have one of the following solid tumor cancers:

1. Monotherapy escalation and backfill cohorts:

   1. non-squamous EGFR-Wt NSCLC
   2. Endometrial carcinoma
   3. Platinum Resistant Ovarian Cancer
2. Monotherapy expansion cohorts:

   1. Non-squamous EGFR-Wt NSCLC
   2. Additional tumor indications to be defined in a future amendment

Exclusion Criteria:

1. Individual with known or suspected uncontrolled central nervous system (CNS) metastases
2. Individual with history of carcinomatous meningitis
3. Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
4. Individual with evidence of corneal keratopathy or history of cornea transplant
5. Any serious unresolved toxicities from prior therapy
6. Significant cardiovascular disease
7. Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥ 470 milliseconds (ms)
8. History of pneumonitis/interstitial lung disease
9. Individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

About the study

HWK-007-101 is a multicenter, open-label, first-in-human (FIH) Phase 1 study evaluating HWK-007, a protein tyrosine kinase 7 (PTK7)-targeted antibody drug conjugate (ADC), in adult participants with advanced or metastatic solid tumors known to be expressing PTK7. The study employs a sequential dose escalation and dose expansion design without a control group.

What is being tested

Sponsor: Whitehawk Therapeutics, Inc. · Participants: 226 · Started: Dec 19, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07444814

Locations in the U.S.

ArkansasUniversity of Arkansas, Little Rock
CaliforniaUCLA - Hematology/Oncology Clinical Research Unit, Los Angeles (Not yet recruiting)
IllinoisSt. Francis Medical Center (OSF Healthcare), Peoria
MichiganSTART - Midwest, Grand Rapids
New JerseyHackensack University Medical Center - John Theurer Cancer Center, Hackensack
New YorkRoswell Park Comprehensive Care Center, Buffalo
OhioUniversity Hospital - Cleveland Medical Center, Cleveland
TexasNEXT Oncology - Austin, Austin
NEXT - Oncology - Houston, Houston
START - San Antonio, San Antonio
VirginiaNEXT Oncology - Virginia Cancer Specialists, Fairfax
WashingtonFred Hutchinson Cancer Center, Seattle (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.