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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
Trial Status: active
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.
Inclusion 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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07444814.
Locations matching your search criteria
United States
New Jersey
Hackensack
Hackensack University Medical Center
Status: Active
Name Not Available
Ohio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
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)
