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 — DRUG
    Single-chain fusion protein comprised of human IL-2, human LAIR2, HSA, and human IL-12, connected via glycine/serine linker sequences
  • Pembrolizumab — DRUG
    Humanized 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)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Orlando HealthOrlandoFlorida32806-
University of ChicagoChicagoIllinois60637-
MD AndersonHoustonTexas77030-
Fred Hutchinson Cancer CenterSeattleWashington98109-

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