Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Pā¦ (NCT07444814) | Clinical Trial Compass
RecruitingPhase 1
Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors
United States226 participantsStarted 2025-12-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Monotherapy escalation and backfill cohorts:
ā. non-squamous EGFR-Wt NSCLC
ā. Endometrial carcinoma
ā. Platinum Resistant Ovarian Cancer
ā. Monotherapy expansion cohorts:
ā. Non-squamous EGFR-Wt NSCLC
ā. Additional tumor indications to be defined in a future amendment
Exclusion criteria
ā. Individual with known or suspected uncontrolled central nervous system (CNS) metastases
ā. Individual with history of carcinomatous meningitis
ā. Individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
ā. Individual with evidence of corneal keratopathy or history of cornea transplant
ā. Any serious unresolved toxicities from prior therapy
ā. Significant cardiovascular disease
ā. Prolongation of QT interval corrected for heart rate using Fridericia's formula (QTcF) ā„ 470 milliseconds (ms)
ā
What they're measuring
1
Determine Maximum Tolerated Dose (MTD)
Timeframe: From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)
2
Determine Maximum Administered Dose (MAD)
Timeframe: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
3
Determine the Recommended Dose for Expansion (RDE)
Timeframe: From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.