Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

Part of paid clinical trials in Los Angeles, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04465487
Phase
PHASE1
Status
Terminated

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Eligibility Criteria

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

Interventions

  • REGN6569 — DRUG
    Administered by intravenous (IV) infusion
  • Cemiplimab — DRUG
    Administered by IV infusion

Study Details

There are two main goals of this study: The first is to find the highest safe dose of REGN6569 when given with cemiplimab. The second is to get some initial information about how well the REGN6569 in combination with cemiplimab may help shrink certain types of cancer. The study is also looking at: * Side effects that may be experienced by people taking REGN6569 alone and with cemiplimab * How REGN6569 and cemiplimab work in the body * How much REGN6569 and cemiplimab is in your blood * To see if REGN6569 can lower the number of Treg cells in tumors * To see if REGN6569 and cemiplimab can shrink tumors when given together

Key Dates

Start date
Oct 5, 2020
Status verified
Feb 2025
Primary completion
Feb 7, 2025
Completion
Feb 7, 2025

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation
    REGN6569 lead-in, then combo therapy
  • Experimental: Dose Expansion
    Randomized 1:1 between cohorts Cohort 1: Concurrent start of REGN6569 + cemiplimab Cohort 2: REGN6569 lead-in, then combo therapy

Primary Outcome Measure

Incidence of dose-limited toxicities (DLTs) [ Time Frame: Up to 42 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Angeles Clinic and Research Institute - Clinic/Outpatient FacilityLos AngelesCalifornia90025-
H.Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-
University of MichiganAnn ArborMichigan48109-
START South Texas Accelerated Research TherapeuticsGrand RapidsMichigan49503-

Find similar trials in Los Angeles, CA

By research site
Angeles Clinic and Research Institute - Clinic/Outpatient Facility· Los Angeles, CAH.Lee Moffitt Cancer Center and Research Institute· Tampa, FLUniversity of Michigan· Ann Arbor, MISTART South Texas Accelerated Research Therapeutics· Grand Rapids, MI

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