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

NCT07444814 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2026-03-27

No results posted yet for this 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.

Conditions

Interventions

DRUG

HWK-007

HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.

Sponsors & Collaborators

  • Whitehawk Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Margaret C Dugan, MD · Whitehawk Therapeutics

  • Edward C 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
2025-12-19
Primary Completion
2028-10-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT07444814 on ClinicalTrials.gov