Study Evaluating the Safety and Efficacy of HWK-007, a PTK7-directed Antibody Drug Conjugate in Participants With Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

HWK-007: HWK-007 is a PTK7- targeted ADC being developed for the treatment of solid tumors.

Study 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.

Eligibility

Primary outcome measure(s)

• Determine Maximum Tolerated Dose (MTD) — From Cycle 1, Day 1 until Cycle 1, Day 21 (21-day cycles)
  Determine the highest dose of HWK-007 that can be administered without signs of toxicity measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
• Determine Maximum Administered Dose (MAD) — From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until the MTD is reached.
  Determine the highest dose administered during the dose escalation part of the study measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).
• Determine the Recommended Dose for Expansion (RDE) — From Cycle 1, Day 1 to Cycle 1, Day 21 (21-day cycles) until MTD is identified.
  Determine the dose that will be recommended for further study within the tumor types studied in this clinical trial measured at the end of Cycle 1 (21 day cycle) by: Incidence and severity of Adverse Events (AE). Incidence of Dose-Limiting Toxicities (DLT). Incidence of Serious Adverse Events (SAE).

Trial sites (12)

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