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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

NCT07444814

RecruitingPhase 1

Sponsor: Whitehawk Therapeutics, Inc.

Conditions: Endometrial Cancer, Ovarian Cancer, Ovarian Cancer Metastatic, Ovarian Cancer Metastatic Recurrent, Non-squamous EGFR Wt NSCLC

Interventions: HWK-007

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (12)

Little Rock, Arkansas, United States
Los Angeles, California, United States
Peoria, Illinois, United States
Grand Rapids, Michigan, United States
Hackensack, New Jersey, United States
Buffalo, New York, United States
Cleveland, Ohio, United States
Austin, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Fairfax, Virginia, United States
Seattle, Washington, United States