CLN-617 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Cullinan Therapeutics Inc.
- Study ID
- NCT06035744
- Phase
- PHASE1
- Status
- Terminated
Conditions
- Advanced Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- CLN-617 — DRUGSingle-chain fusion protein comprised of human IL-2, human LAIR2, HSA, and human IL-12, connected via glycine/serine linker sequences
- Pembrolizumab — DRUGHumanized IgG4 anti-PD-1 monoclonal antibody
Study Details
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
Key Dates
- First listed
- Sep 13, 2023
- Start date
- Dec 12, 2023
- Status verified
- Jun 2026
- Primary completion
- Jun 16, 2026
- Completion
- Jun 16, 2026
Study Design
- Enrollment
- 23 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: CLN-617 Dose Escalation (Part A)Patients with Advanced Solid Tumors enrolled in dose escalation cohorts treated with CLN-617 alone and in combination with pembrolizumab
- Experimental: CLN-617 Dose Optimization (Part B)Patients with Advanced Solid Tumors enrolled in dose optimization receiving selected doses of CLN-617 in combination with pembrolizumab
- Experimental: CLN-617 Dose Expansion (Part C)Patients with Advanced Melanoma or Head and Neck Squamous Cell Carcinoma (HNSCC) enrolled in dose expansion treated with CLN-617 in combination with pembrolizumab
Primary Outcome Measure
Dose Escalation [ Time Frame: 24 Months ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | - |
| Orlando Health | Orlando | Florida | 32806 | - |
| University of Chicago | Chicago | Illinois | 60637 | - |
| MD Anderson | Houston | Texas | 77030 | - |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | - |
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