A Study of CLN-619 Alone and in Combination With Pembrolizumab in Advanced Solid Tumors

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Cullinan Therapeutics Inc.
Study ID
NCT05117476
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Advanced Solid Tumor
  • NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CLN-619 — DRUG
    Anti-MICA/MICB monoclonal antibody
  • Pembrolizumab — DRUG
    Keytruda
  • Paclitaxel — DRUG
    Taxane
  • Carboplatin AUC 6 — DRUG
    Platinum compound
  • pemetrexed — DRUG
    antifolate
  • Datopotamab deruxtecan-dlnk (Dato-DXd) — DRUG
    TROP-2 antibody-drug conjugate (ADC)

Study Details

CLN-619-001 is a Phase 1, open-label, multi-center study of CLN-619 alone and in combination with pembrolizumab in patients with advanced solid tumors.

Key Dates

Start date
Oct 29, 2021
Status verified
Oct 2025
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
440 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Module A Dose Escalation
    Patients with advanced solid tumors enrolled in dose escalation cohorts treated with CLN-619
  • Experimental: Module A Cohort Expansion
    Patients with select solid tumor types enrolled in expansion cohorts treated with CLN-619 at a dose selected from the Module A Escalation arm
  • Experimental: Module B Combination Therapy Dose Escalation
    Patients with advanced solid tumors enrolled in dose escalation cohorts treated with CLN-619 in combination with pembrolizumab
  • Experimental: Module B Combination Therapy Cohort Expansion
    Patients with select tumor types enrolled in expansion cohorts treated with CLN-619 at a dose selected from the Module B Escalation arm, in combination with pembrolizumab
  • Experimental: Module C Escalation and Expansion
    Patients with select tumor types taking CLN-619 in combination with chemotherapy
  • Experimental: Module D Loading Dose
    Patients with select tumor types taking a loading dose of CLN-619
  • Experimental: Module E Safety Run-in and Expansion
    Patients with select NSCLC tumor types taking CLN-619 in combination with Dato-DXd

Primary Outcome Measure

Dose Escalation: TEAEs [ Time Frame: 24 Months ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233-
City of HopeDuarteCalifornia91010-
City of HopeIrvineCalifornia92618-
Florida Cancer SpecialistsSarasotaFlorida34232-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
START MidwestGrand RapidsMichigan49546-
Hackensack Meridian HealthHackensackNew Jersey07601-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Carolina BioOncology InstituteHuntersvilleNorth Carolina28078-
Sarah Cannon Research InstituteNashvilleTennessee37203-
START San AntonioSan AntonioTexas78229-
Virginia Cancer CenterFairfaxVirginia22031-

Find similar trials in Birmingham, AL

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope· Duarte, CACity of Hope· Irvine, CAFlorida Cancer Specialists· Sarasota, FLDana-Farber Cancer Institute· Boston, MASTART Midwest· Grand Rapids, MI

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