A Phase 1, First-in-Human Study of CUSP06, a Cadherin-6 (CDH6)-Directed Antibody-Drug Conjugate, in Patients With Platinum-Refractory/Resistant Ovarian Cancer and Other Advanced Solid Tumors
OnCusp Therapeutics, Inc.
Summary
This phase 1 study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of CUSP06 in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent provided prior to any screening procedures. * Male or female patients, ≥18 years of age at the time of obtaining informed consent. * Patients with histologically or cytologically confirmed advanced solid tumors previously treated with standard of care systemic therapy, or for whom no standard therapy is available. * Willingness to provide archival tumor tissue, when available. If no archival tissue is available, willingness to undergo a pretreatment biopsy if medically feasible and safe. * Measurable disease per RECIST v1.1. * Eastern Cooperative…
Interventions
- DrugCUSP06
Antibody drug conjugate (ADC)
Locations (15)
- Sarah Cannon Research Institute at HealthONEDenver, Colorado
- Yale UniversityNew Haven, Connecticut
- Mount Sinai Medical CenterMiami Beach, Florida
- Florida Cancer SpecialistsSarasota, Florida
- Dana Farber Cancer InstituteBoston, Massachusetts
- START MidwestGrand Rapids, Michigan