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RecruitingInterventionalPhase 1/Phase 2

A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors

NCT ID: NCT04626635Sponsor: Regeneron PharmaceuticalsLast updated: 2026-04-09

Summary

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)

Arms & interventions

  • DrugREGN7075

    Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)

  • DrugCemiplimab

    Administered concomitantly Q3W by IV infusion or SC injection

  • DrugPlatinum-based doublet chemotherapy

    Administered IV Q3W

  • DrugBevacizumab

    Administered per protocol

  • DrugTrifluridine-tipiracil

    Administered per protocol

Outcome measures

Primary

  • The incidence of Dose-Limiting Toxicities (DLTs) during the DLT period

    Dose escalation

    Time frame: Up to 6 weeks

  • Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)

    Dose escalation

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Incidence and severity of Adverse Events of Special Interest (AESIs)

    Dose escalation

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Incidence and severity of Serious Adverse Events (SAEs)

    Dose escalation

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Incidence and severity of grade ≥3 laboratory abnormalities

    Dose escalation

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Objective Response Rate (ORR)

    Dose expansion

    Time frame: Up to 5 years

Secondary

  • Concentrations of marlotamig in serum

    Time frame: Up to 5 years

  • ORR

    Time frame: Up to 5 years

  • Progression Free Survival (PFS)

    Time frame: Up to 5 years

  • Duration of Response (DOR)

    Time frame: Up to 5 years

  • Disease Control Rate (DCR)

    Time frame: Up to 5 years

  • Complete Response (CR) rate

    Time frame: Up to 5 years

  • Overall survival (OS)

    Time frame: Up to 5 years

  • Incidence of Anti-Drug Antibodies (ADA) to marlotamig

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Magnitude of ADA to marlotamig

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Incidence of ADA to cemiplimab

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Magnitude of ADA to cemiplimab

    Time frame: Approximately 90 days from last dose; up to 5 years

  • The incidence and severity of TEAEs

    Time frame: Approximately 90 days from last dose; up to 5 years

  • The incidence and severity of AESIs

    Time frame: Approximately 90 days from last dose; up to 5 years

  • The incidence and severity of SAEs

    Time frame: Approximately 90 days from last dose; up to 5 years

  • The incidence and severity of grade ≥3 laboratory abnormalities

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported Quality of Life (QoL) per European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported Quality of Life (QoL) per EORTC QLQ-CR29 in CRC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported Quality of Life (QoL) per EORTC QLQ-BR23 in breast cancer patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported Quality of Life (QoL) per EORTC QLQ-LC13 in NSCLC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported Quality of Life (QoL) per EORTC QLQ-HN35 in HNSCC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported Quality of Life (QoL) per EQ-5D-5L

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported symptoms per EORTC QLQ-C30

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported symptoms per EORTC QLQ-CR29 in CRC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported symptoms per EORTC QLQ-BR23 in breast cancer patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported symptoms per EORTC QLQ-LC13 in NSCLC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported symptoms per EORTC QLQ-HN35 in HNSCC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported symptoms per EQ-5D-5L

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported functioning per EORTC QLQ-C30

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported functioning per EORTC QLQ-CR29 in CRC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported functioning per EORTC QLQ-BR23 in breast cancer patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported functioning per EORTC QLQ-LC13 in NSCLC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported functioning per EORTC QLQ-HN35 in HNSCC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reported functioning per EQ-5D-5L

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reporting general health status per EORTC QLQ-C30

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reporting general health status per EORTC QLQ-CR29 in CRC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reporting general health status per EORTC QLQ-BR23 in breast cancer patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reporting general health status per EORTC QLQ-LC13 in NSCLC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reporting general health status per EORTC QLQ-HN35 in HNSCC patients

    Time frame: Approximately 90 days from last dose; up to 5 years

  • Patient reporting general health status per EQ-5D-5L

    Time frame: Approximately 90 days from last dose; up to 5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Key Inclusion Criteria: 1. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 2. Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol 3. Expansion Cohorts only: Is anti-Programmed cell Death protein-1 (PD-1)/Programmed cell Death Ligand-1 (PD-L1) naïve, defined as never having previously been treated with a drug that targets the PD-1 4. Has at least 1 lesion that meets study criteria as defined in the protocol 5. Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated 6. Has adequate organ and bone marrow function as defined in the protocol 7. In the judgement of the investigator, has a life expectancy of at least 3 months Key Exclusion Criteria: 1. Is currently participating in another study of a therapeutic agent 2. Has participated in any study of an investigational agent or an investigational device within 4 weeks of the first administration of study drug as defined in the protocol 3. Has received treatment with an approved systemic therapy within 4 weeks of the first administration of study drug or has not yet recovered (ie, grade 1 or baseline) from any acute toxicities 4. Has received recent anti-Epidermal Growth Factor Receptor (EGFR) antibody therapy as defined in the protocol 5. Has received radiation therapy or major surgery within 14 days of the first administration of study drug or has not recovered (ie, grade 1 or baseline) from adverse events 6. Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug. 7. Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol 8. Has second malignancy that is progressing or requires active treatment as defined in the protocol 9. Has any condition requiring ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks prior to the first dose of study drug as defined in the protocol 10. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments as defined in the protocol 11. Has untreated or active primary brain tumor, Central Nervous System (CNS) metastases, leptomeningeal disease, or spinal cord compression 12. Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug 13. Has any ongoing inflammatory skin disease as defined in the protocol NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Study locations (21)

Valkyrie Clinical Trials

Los Angeles, California, 90067

Recruiting

University of California Los Angeles (UCLA) Medical Center

Los Angeles, California, 90095

Recruiting

The Regents of the University of California, San Francisco

San Francisco, California, 94118

Recruiting

University of Colorado Hospital - Anschutz Cancer Pavilion - Lung Cancer Clinic

Aurora, Colorado, 80045

Recruiting

University of Florida Health

Gainesville, Florida, 32608

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Completed

University of Illinois Cancer Center

Chicago, Illinois, 60612

Recruiting

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242

Recruiting

Dana Farber Cancer Institute Brookline Avenue

Boston, Massachusetts, 02215

Withdrawn

START Midwest - Cancer & Hematology Centers of Western Michigan, PC

Grand Rapids, Michigan, 49546

Recruiting

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901

Recruiting

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

Recruiting

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219

Recruiting

The Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, 43212

Completed

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Recruiting

Sarah Cannon Research Institute - 25th Ave

Nashville, Tennessee, 37203

Recruiting

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, 37232

Recruiting

MD Anderson Cancer Center

Houston, Texas, 77030

Recruiting

South Texas Oncology And Hematology

San Antonio, Texas, 78229

Completed

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington, 98109

Recruiting

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting