Clinical Trials /

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

NCT04626635

Description:

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

Related Conditions:
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors
  • Official Title: A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: R7075-ONC-2009
  • NCT ID: NCT04626635

Conditions

  • Advanced Solid Tumors

Interventions

DrugSynonymsArms
REGN7075Dose Escalation
cemiplimabREGN2810, LibtayoDose Escalation

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Dose EscalationExperimentalVariety of mixed advanced solid tumor types
  • REGN7075
  • cemiplimab
Dose Expansion AExperimentalMicrosatellite-Stable Colorectal Cancer (MSS CRC)
  • REGN7075
  • cemiplimab
Dose Expansion BExperimentalTriple Negative Breast Cancer (TNBC)
  • REGN7075
  • cemiplimab
Dose Expansion CExperimentalCutaneous Squamous Cell Carcinoma (CSCC)
  • REGN7075
  • cemiplimab
Dose Expansion DExperimentalNon-Small Cell Lung Cancer (NSCLC)
  • REGN7075
  • cemiplimab

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The incidence of dose-limiting toxicities (DLTs) during the DLT period
Time Frame:Up to 6 weeks
Safety Issue:
Description:Dose escalation

Secondary Outcome Measures

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

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Regeneron Pharmaceuticals

Trial Keywords

  • Variety of mixed advanced solid tumor types
  • First in Human (FIH)

Last Updated

November 12, 2020