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

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ClinicalTrials.gov Identifier: NCT04626635
Recruitment Status : Recruiting
First Posted : November 12, 2020
Last Update Posted : November 11, 2021
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: REGN7075 Drug: cemiplimab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 402 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of REGN7075 (EGFRxCD28 Costimulatory Bispecific Antibody) in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Actual Study Start Date : December 21, 2020
Estimated Primary Completion Date : April 3, 2025
Estimated Study Completion Date : April 3, 2025

Arm Intervention/treatment
Experimental: Dose Escalation
Variety of mixed advanced solid tumor types
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

Experimental: Dose Expansion A
Microsatellite-Stable Colorectal Cancer (MSS CRC)
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

Experimental: Dose Expansion B
Triple Negative Breast Cancer (TNBC)
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

Experimental: Dose Expansion C
Cutaneous Squamous Cell Carcinoma (CSCC)
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

Experimental: Dose Expansion D
Non-Small Cell Lung Cancer (NSCLC)
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

Experimental: Dose Expansion E
Head and Neck Squamous Cell Carcinoma (HNSCC)
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




Primary Outcome Measures :
  1. The incidence of dose-limiting toxicities (DLTs) during the DLT period [ Time Frame: Up to 6 weeks ]
    Dose escalation

  2. Incidence and severity of treatment emergent adverse events (TEAEs) [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
    Dose escalation

  3. Incidence and severity of adverse events of special interest (AESIs) [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
    Dose escalation

  4. Incidence and severity of serious adverse events (SAEs) [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
    Dose escalation

  5. Incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
    Dose escalation

  6. Objective Response Rate (ORR) [ Time Frame: Up to 5 years ]
    Dose expansion


Secondary Outcome Measures :
  1. Drug concentrations of REGN7075 in serum [ Time Frame: Up to 5 years ]
    Dose escalation and dose expansion

  2. Drug concentrations of cemiplimab [ Time Frame: Up to 5 years ]
    Dose escalation and dose expansion

  3. ORR [ Time Frame: Up to 5 years ]
    Dose escalation

  4. Progression free survival (PFS) [ Time Frame: Up to 5 years ]
    Dose escalation and dose expansion

  5. Duration of Response (DOR) [ Time Frame: Up to 5 years ]
    Dose escalation and dose expansion

  6. Disease control rate (DCR) [ Time Frame: Up to 5 years ]
    Dose escalation and dose expansion

  7. Complete response (CR) rate [ Time Frame: Up to 5 years ]
    Dose escalation and dose expansion

  8. Overall survival (OS) [ Time Frame: Up to 5 years ]
    Dose escalation and dose expansion

  9. 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

  10. Incidence of ADA to cemiplimab [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
    Dose escalation and dose expansion

  11. The incidence and severity of TEAEs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
    Dose expansion

  12. The incidence and severity of AESIs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
    Dose expansion

  13. The incidence and severity of SAEs [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
    Dose expansion

  14. The incidence and severity of grade ≥3 laboratory abnormalities [ Time Frame: Approximately 90 days from last dose; up to 5 years ]
    Dose expansion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04626635


Contacts
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Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
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United States, Massachusetts
Regeneron Research Site Recruiting
Boston, Massachusetts, United States, 02215
United States, Michigan
Regeneron Research Site Recruiting
Grand Rapids, Michigan, United States, 49546
United States, New Jersey
Regeneron Research Site Recruiting
New Brunswick, New Jersey, United States, 08903
United States, New York
Regeneron Research Site Recruiting
New York, New York, United States, 10065
United States, Pennsylvania
Regeneron Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Regeneron Research Site Recruiting
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
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Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04626635    
Other Study ID Numbers: R7075-ONC-2009
First Posted: November 12, 2020    Key Record Dates
Last Update Posted: November 11, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Regeneron Pharmaceuticals:
Variety of mixed advanced solid tumor types
First in Human (FIH)
Additional relevant MeSH terms:
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Neoplasms
Cemiplimab
Antineoplastic Agents, Immunological
Antineoplastic Agents