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REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors (COMBINE-EGFR-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04626635
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : December 22, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 6, 2020
First Posted Date  ICMJE November 12, 2020
Last Update Posted Date December 22, 2021
Actual Study Start Date  ICMJE December 21, 2020
Estimated Primary Completion Date April 3, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 6, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REGN7075 in Combination With Cemiplimab in Adult Participants With Advanced Solid Tumors
Official Title  ICMJE A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Brief Summary

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

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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Solid Tumors
Intervention  ICMJE
  • Drug: REGN7075
    Intravenous (IV) infusion or subcutaneous (SC) injection will be administered every week (QW) or every 3 weeks (Q3W)
  • Drug: cemiplimab
    administered concomitantly Q3W by IV infusion or SC injection
    Other Names:
    • REGN2810
    • Libtayo
Study Arms  ICMJE
  • Experimental: Dose Escalation
    Variety of mixed advanced solid tumor types
    Interventions:
    • Drug: REGN7075
    • Drug: cemiplimab
  • Experimental: Dose Expansion A
    Microsatellite-Stable Colorectal Cancer (MSS CRC)
    Interventions:
    • Drug: REGN7075
    • Drug: cemiplimab
  • Experimental: Dose Expansion B
    Triple Negative Breast Cancer (TNBC)
    Interventions:
    • Drug: REGN7075
    • Drug: cemiplimab
  • Experimental: Dose Expansion C
    Cutaneous Squamous Cell Carcinoma (CSCC)
    Interventions:
    • Drug: REGN7075
    • Drug: cemiplimab
  • Experimental: Dose Expansion D
    Non-Small Cell Lung Cancer (NSCLC)
    Interventions:
    • Drug: REGN7075
    • Drug: cemiplimab
  • Experimental: Dose Expansion E
    Head and Neck Squamous Cell Carcinoma (HNSCC)
    Interventions:
    • Drug: REGN7075
    • Drug: cemiplimab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2021)
402
Original Estimated Enrollment  ICMJE
 (submitted: November 6, 2020)
312
Estimated Study Completion Date  ICMJE April 3, 2025
Estimated Primary Completion Date April 3, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. 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
  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-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, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04626635
Other Study ID Numbers  ICMJE R7075-ONC-2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
URL: https://vivli.org/
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP