A Trial to Find Out How Safe REGN7075 is and How Well it Works in Combination With Cemiplimab for Adult Participants With Advanced Cancers

Part of paid clinical trials in Los Angeles, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT04626635
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • REGN7075 — DRUG
    Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
  • Cemiplimab — DRUG
    Administered concomitantly Q3W by IV infusion or SC injection
  • Platinum-based doublet chemotherapy — DRUG
    Administered IV Q3W
  • Bevacizumab — DRUG
    Administered per protocol
  • Trifluridine-tipiracil — DRUG
    Administered per protocol

Study Details

This study is researching an investigational drug called marlotamig (REGN7075) by itself and in combination with cemiplimab with or without chemotherapy. The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe and tolerable marlotamig is by itself and in combination with cemiplimab (with or without chemotherapy), and to find out what is the best dose of marlotamig to be given to patients with advanced solid tumors when combined with cemiplimab (with or without chemotherapy). Another aim of the study is to see how effective marlotamig by itself, or in combination with cemiplimab (with or without chemotherapy), is at treating cancer patients. The study is also looking at: * Side effects that may be experienced by people taking marlotamig by itself and in combination with cemiplimab with or without chemotherapy * How marlotamig works in the body by itself and in combination with cemiplimab with or without chemotherapy * How much marlotamig is present in the blood when given by itself and in combination with cemiplimab with or without chemotherapy * To see if marlotamig by itself and in combination with cemiplimab with or without chemotherapy works to treat cancer by controlling the proliferation of tumor cells to shrink the tumor * Whether the body makes antibodies against the study drugs (marlotamig and cemiplimab) (which could make the drug less effective or could lead to side effects)

Key Dates

Start date
Dec 21, 2020
Status verified
Jan 2026
Primary completion
Aug 19, 2026
Completion
Apr 7, 2027

Study Design

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

Arms

  • Experimental: Dose Escalation
    Variety of mixed advanced solid tumor types
  • Experimental: Dose Expansion A
    Triple Negative Breast Cancer (TNBC)
  • Experimental: Dose Expansion B
    Cutaneous Squamous Cell Carcinoma (CSCC)
  • Experimental: Dose Expansion C
    Non-Small Cell Lung Cancer (NSCLC)
  • Experimental: Dose Expansion D
    Head and Neck Squamous Cell Carcinoma (HNSCC)
  • Experimental: Dose Expansion E
    Microsatellite Stable-Colorectal Cancer (MSS-CRC), with Active Liver Metastases and/or Active Peritoneal Metastases
  • Experimental: Dose Expansion F
    MSS-CRC with Isolated Lung/Lymph Node Metastases (no active liver and no active peritoneal metastases)
  • Experimental: Dose Expansion G
    Epidermal Growth Factor Receptor (EGFR) -mutant NSCLC Post Third Generation tyrosine kinase inhibitor (TKI)
  • Experimental: Dose Expansion H
    EGFR-mutant NSCLC Post Third Generation TKI and Post Platinum-Doublet Chemotherapy
  • Experimental: Dose Expansion I
    Third-line (3L) MSS-CRC with Active Liver Metastases
  • Experimental: Dose Expansion J
    3L MSS-CRC without Active Liver Metastases

Primary Outcome Measure

The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period [ Time Frame: Up to 6 weeks ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
University of California Los Angeles (UCLA) Medical CenterLos AngelesCalifornia90095-
Valkyrie Clinical TrialsLos AngelesCalifornia90067-
The Regents of the University of California, San FranciscoSan FranciscoCalifornia94118-
University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer ClinicAuroraColorado80045-
University of Florida HealthGainesvilleFlorida32608-
Moffitt Cancer CenterTampaFlorida33612-
University of Illinois Cancer CenterChicagoIllinois60612-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Dana Farber Cancer Institute Brookline AvenueBostonMassachusetts02215-
START Midwest - Cancer & Hematology Centers of Western Michigan, PCGrand RapidsMichigan49546-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of Cincinnati Medical CenterCincinnatiOhio45219-
The Stefanie Spielman Comprehensive Breast CenterColumbusOhio43212-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Sarah Cannon Research Institute - 25th AveNashvilleTennessee37203-
Vanderbilt Ingram Cancer CenterNashvilleTennessee37232-
MD Anderson Cancer CenterHoustonTexas77030-
South Texas Oncology And HematologySan AntonioTexas78229-
University of Washington/Fred Hutchinson Cancer CenterSeattleWashington98109-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By research site
University of California Los Angeles (UCLA) Medical Center· Los Angeles, CAValkyrie Clinical Trials· Los Angeles, CAThe Regents of the University of California, San Francisco· San Francisco, CAUniversity of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic· Aurora, COUniversity of Florida Health· Gainesville, FLMoffitt Cancer Center· Tampa, FL

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