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
Recruiting
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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

Start date
Dec 12, 2023
Status verified
Feb 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
86 participants (estimated)
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 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Anthony El-Khoureiy, MD (PRINCIPAL_INVESTIGATOR)
Orlando HealthOrlandoFlorida32806
Tirrell Johnson (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Randy Sweis (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Alexandra Ikeguchi (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Evan Hall (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
USC Norris Comprehensive Cancer Center· Los Angeles, CAOrlando Health· Orlando, FLUniversity of Chicago· Chicago, ILMD Anderson· Houston, TXFred Hutchinson Cancer Center· Seattle, WA

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