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

Study Identifier:
R7075-ONC-2009
CT.gov Identifier:
NCT04626635
EudraCT Identifier:
202250000000
EU Trial (CTIS) Number:
2022-501234-37-00
Study Contact Information:
(210) 593-5651 or [email protected]
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Study Summary

To assess the safety, efficacy and tolerability of a REGN7075 monotherapy lead-in and REGN7075 in combination with cemiplimab in patients with advanced solid tumors tumors

To study the pharmacokinetics (PK) and immunogenicity of REGN7075 alone and in combination with cemiplimab.

To evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of REGN7075 (EGFRxCD28) alone and in combination with cemiplimab (anti-programmed cell death [PD]-1) in patients with advanced solid tumors

To evaluate the safety, tolerability, PK, and anti-tumor activity of REGN7075 ± cemiplimab (anti–PD-1) in patients (pts) with solid tumors

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: Dose Escalation
    • Read More
  • Drug: Drug: Cemiplimab
  • Drug: Other Names:
  • Drug: Experimental: Dose Expansion D
  • Drug: Experimental: Dose Expansion H
  • Drug: Drug: Trifluridine-tipiracil
  • Drug: Experimental: Dose Expansion J
  • Drug: In Part 1, pts will receive a 3-week REGN7075 monotherapy once-weekly (QW) lead-in prior to combination therapy with REGN7075 QW or every 3 weeks (Q3W) + cemiplimab Q3W. Concurrent Q3W dosing with cemiplimab may be conducted for dose levels for which the lead-in is tolerable; to date, this has been up to a dose of 900 mg.
  • Drug: Patients first receive a weekly lead-in dose of REGN7075 monotherapy for three weeks to assess its safety and efficacy alone. This is followed by treatment with combination therapy, with Libtayo dosed once every three weeks and REGN7075 dosed either every week or every three weeks.
  • Drug: Patients received REGN7075 QW/Q3W + cemi Q3W, including a 3-week REGN7075 monotherapy QW lead-in
  • Drug: WCLC 2024:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    Inclusion criteria
    • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
    • Has histologically or cytologically confirmed cancer that meets criteria as defined in the protocol
    • 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
    • Has at least 1 lesion that meets study criteria as defined in the protocol
    • Willing to provide tumor tissue from newly obtained biopsy (at a minimum core biopsy) from a tumor site that has not been previously irradiated
    • Has adequate organ and bone marrow function as defined in the protocol
    • In the judgement of the investigator, has a life expectancy of at least 3 months
    • Overall, key inclusion criteria are: evidence of a protocol-defined advanced solid tumor, an ECOG performance status of 0 or 1, and no previous anti–PD-1/anti–PD-(L)1 therapy (Part 2 only). The analyses of Part 1 will be descriptive and exploratory in nature
    Exclusion criteria
    • Is currently participating in another study of a therapeutic agent
    • 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
    • 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
    • Has received recent anti-epidermal growth factor receptor (EGFR) antibody therapy as defined in the protocol
    • 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
    • Has received any previous systemic, non-immunomodulatory biologic therapy within 4 weeks of first administration of study drug.
    • Has had prior anti-cancer immunotherapy within 5 half-lives prior to study drug as defined in the protocol
    • Has second malignancy that is progressing or requires active treatment as defined in the protocol
    • 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
    • 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
    • Has untreated or active primary brain tumor, CNS metastases, leptomeningeal disease, or spinal cord compression
    • Has encephalitis, meningitis, organic brain disease (eg, Parkinson's disease) or uncontrolled seizures within 1 year prior to the first dose of study drug
    • Has any ongoing inflammatory skin disease as defined in the protocol NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor