A Phase 1 First-in-Human Study to Investigate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamic Activity of CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Cullinan Therapeutics Inc.
Summary
CLN-617-001 is a Phase 1, open-label, dose escalation, dose optimization and dose expansion study of CLN-617 alone and in combination with Pembrolizumab in patients with advanced solid tumors
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Aged ≥ 18 years. 2. Patient should have previously received or had a contraindication to standard therapy that confers an overall survival benefit. 3. Part 1 Dose Escalation Cohorts: Histologically or cytologically confirmed advanced incurable or metastatic non-neurological solid tumor with accessible injectable lesions. 4. Part 2 Dose Optimization: Histologically or cytologically confirmed select advanced incurable or metastatic cancer types with accessible injectable lesions. 5. Part 3 Dose Expansions: 1. Cohort 1: Histologically or cytologically confirmed metasta…
Interventions
- DrugCLN-617
Single-chain fusion protein comprised of human IL-2, human LAIR2, HSA, and human IL-12, connected via glycine/serine linker sequences
- DrugPembrolizumab
Humanized IgG4 anti-PD-1 monoclonal antibody
Locations (5)
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- Orlando HealthOrlando, Florida
- University of ChicagoChicago, Illinois
- MD AndersonHouston, Texas
- Fred Hutchinson Cancer CenterSeattle, Washington