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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

Sponsored by Whitehawk Therapeutics, Inc.

About this 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.

The study consists of 2 phases, Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, participants with non-squamous Endothelial Growth Factor Receptor Wild type (EGFR Wt) NSCLC, platinum resistant ovarian cancer (PROC), and endometrial cancer will be enrolled. In Phase 1b, non-squamous EGFR Wt NSCLC expansion cohort(s) will be opened, based on the safety, tolerability, PK, and preliminary antitumor data in Phase 1a. In Phase 1a of the study, HWK-007 will initially be administered as an intravenous (IV) infusion every 3 weeks (Q3W).

Where this study is enrolling (12)

  • University of Arkansas

    Little Rock, Arkansas

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  • UCLA - Hematology/Oncology Clinical Research Unit

    Los Angeles, California

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  • St. Francis Medical Center (OSF Healthcare)

    Peoria, Illinois

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  • START - Midwest

    Grand Rapids, Michigan

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  • Hackensack University Medical Center - John Theurer Cancer Center

    Hackensack, New Jersey

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Who can participate

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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.