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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedHWK-007

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · EGFR · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 5, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1

Interventional

Where is it offered?12 U.S. locations

Locations may change over time.

Who runs it?Whitehawk Therapeutics, Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Whitehawk Therapeutics, Inc.
Interventions being studied: Drug: HWK-007

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→Recurrent or relapsed→

Biomarkers

EGFR→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of ArkansasLittle Rock, Arkansas
UCLA - Hematology/Oncology Clinical Research UnitLos Angeles, California
St. Francis Medical Center (OSF Healthcare)Peoria, Illinois
START - MidwestGrand Rapids, Michigan
Hackensack University Medical Center - John Theurer Cancer CenterHackensack, New Jersey
Roswell Park Comprehensive Care CenterBuffalo, New York
University Hospital - Cleveland Medical CenterCleveland, Ohio
NEXT Oncology - AustinAustin, Texas
NEXT - Oncology - HoustonHouston, Texas
START - San AntonioSan Antonio, Texas
NEXT Oncology - Virginia Cancer SpecialistsFairfax, Virginia
Fred Hutchinson Cancer CenterSeattle, Washington

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 5, 2026. Always confirm current availability with the study team.

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