HWK-007, a PTK7-targeted antibody‑drug conjugate for advanced PTK7-positive ovarian, endometrial, and certain non‑squamous lung cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human, open-label Phase 1 study uses sequential dose escalation (Phase 1a) followed by dose expansion (Phase 1b) without a control group to define a safe dose and gather early signs of anti-tumor activity and pharmacokinetics. HWK-007, a PTK7-directed antibody‑drug conjugate, is given by intravenous infusion every three weeks during the dose-escalation phase. Phase 1a enrolls patients with non-squamous EGFR wild-type NSCLC, platinum-resistant ovarian cancer, and endometrial carcinoma, and Phase 1b may open expansion cohorts for non-squamous EGFR WT NSCLC and other indications based on initial safety and activity. The trial is multicenter and will open cohorts at selected U.S. oncology centers.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Arkansas
  Little Rock, Arkansas, United States Recruiting
• St. Francis Medical Center (OSF Healthcare)
  Peoria, Illinois, United States Recruiting
• START - Midwest
  Grand Rapids, Michigan, United States Recruiting
• Hackensack University Medical Center - John Theurer Cancer Center
  Hackensack, New Jersey, United States Recruiting
• Roswell Park Comprehensive Care Center
  Buffalo, New York, United States Recruiting
• University Hospital - Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Clinical Trial Manager Lead
• Email: WHWK-Clinical-Trials@whitehawktx.com
• Phone: 866-742-9495

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.