REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors

Overview

The primary objective of the study is: Dose Escalation: • To assess the safety and tolerability of a REGN7075 monotherapy lead-in and REGN7075 in combination with cemiplimab in patients with advanced solid tumors that are naïve to anti-PD-1/PD-L1 therapies Dose Expansion: • To assess the preliminary efficacy of REGN7075 in combination with cemiplimab within selected advanced solid tumor-specific cohorts, as measured by objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and/or composite response criteria The secondary objectives of the study are: Dose Escalation: – To characterize the pharmacokinetics (PK) of REGN7075 alone and in combination with cemiplimab – To assess the preliminary efficacy of REGN7075 in combination with cemiplimab, as measured by ORR, overall survival (OS), progression free survival (PFS), duration of response (DOR), complete response (CR) rate, and disease control rate (DCR) per RECIST 1.1 and/or composite response criteria – To assess immunogenicity of REGN7075 and cemiplimab Dose Expansion: – To assess the preliminary efficacy of REGN7075 in combination with cemiplimab within selected advanced solid tumor-specific cohorts of patients as measured by OS, PFS, DOR, CR rate, and DCR per RECIST 1.1 and/or composite response criteria – To assess the safety and tolerability of REGN7075 in combination with cemiplimab – To characterize the PK of REGN7075 alone and in combination with cemiplimab – To assess immunogenicity to REGN7075 and cemiplimab

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2025

Interventions

  • Drug: REGN7075
    • Intravenous (IV) infusion will be administered every week (QW) or every 3 weeks (Q3W)
  • Drug: cemiplimab
    • administered concomitantly Q3W by IV infusion

Arms, Groups and Cohorts

  • Experimental: Dose Escalation
    • Variety of mixed advanced solid tumor types
  • Experimental: Dose Expansion A
    • Microsatellite-Stable Colorectal Cancer (MSS CRC)
  • Experimental: Dose Expansion B
    • Triple Negative Breast Cancer (TNBC)
  • Experimental: Dose Expansion C
    • Cutaneous Squamous Cell Carcinoma (CSCC)
  • Experimental: Dose Expansion D
    • Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of dose-limiting toxicities (DLTs) during the DLT period
    • Time Frame: Up to 6 weeks
    • Dose escalation
  • Incidence and severity of treatment emergent adverse events (TEAEs)
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose escalation
  • Incidence and severity of adverse events of special interest (AESIs)
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose escalation
  • Incidence and severity of serious adverse events (SAEs)
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose escalation
  • Incidence and severity of grade ≥3 laboratory abnormalities
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose escalation
  • Objective Response Rate (ORR)
    • Time Frame: Up to 5 years
    • Dose expansion

Secondary Measures

  • Drug concentrations of REGN7075 in serum
    • Time Frame: Up to 5 years
    • Dose escalation and dose expansion
  • Drug concentrations of cemiplimab
    • Time Frame: Up to 5 years
    • Dose escalation and dose expansion
  • ORR
    • Time Frame: Up to 5 years
    • Dose escalation
  • Progression free survival (PFS)
    • Time Frame: Up to 5 years
    • Dose escalation and dose expansion
  • Duration of Response (DOR)
    • Time Frame: Up to 5 years
    • Dose escalation and dose expansion
  • Disease control rate (DCR)
    • Time Frame: Up to 5 years
    • Dose escalation and dose expansion
  • Complete response (CR) rate
    • Time Frame: Up to 5 years
    • Dose escalation and dose expansion
  • Overall survival (OS)
    • Time Frame: Up to 5 years
    • Dose escalation and dose expansion
  • Incidence of anti-drug antibodies (ADA) to REGN7075
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose escalation and dose expansion
  • Incidence of ADA to cemiplimab
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose escalation and dose expansion
  • The incidence and severity of TEAEs
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose expansion
  • The incidence and severity of AESIs
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose expansion
  • The incidence and severity of SAEs
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose expansion
  • The incidence and severity of grade ≥3 laboratory abnormalities
    • Time Frame: Approximately 90 days from last dose; up to 5 years
    • Dose expansion

Participating in This Clinical Trial

Key Inclusion Criteria:

1. ≥18 years of age (≥20 years of age for patients enrolled in Japan) 2. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 3. Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol 4. Is anti-PD-1/PD-L1 naïve, defined as never having previously been treated with a drug that targets the PD-1 or PD-L1 pathway 5. Has at least 1 lesion that meets study criteria as defined in the protocol 6. Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated 7. Has adequate organ and bone marrow function as defined in the protocol 8. 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-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, 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regeneron Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trial Management, Study Director, Regeneron Pharmaceuticals
  • Overall Contact(s)
    • Clinical Trials Administrator, 844-734-6643, clinicaltrials@regeneron.com

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