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Phase 1, Open-Label study for patients in Patients With Advanced Malignancies

A Phase 1, Open-Label, Dose-Escalation and Cohort Expansion First-in-Human Study of the Safety, Tolerability, Activity and Pharmacokinetics of REGN3767 (Anti-LAG-3 mAb) Administered Alone or in Combination With REGN2810 (Anti-PD-1 mAb) in Patients With Advanced Malignancies

  • Clinical Trial Information

    Trial Contact: Donaldson, Karin M; Grofsik, Kiera

    Trial Phone: 321.841.9821 ; 321-841-6626

  • IRB No: 20.078.05

    Protocol Abbrev: R3767-ONC-1613

    Principal Investigator: Sajeve Samuel Thomas, MD

    Phase: Drug: Phase I

    Age Group: Adult

    Secondary Protocol No: R3767-ONC-1613

    Treatment: Experimental: Monotherapy (REGN3767) Group A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion. Experimental: Combination Therapy (REGN3767+cemiplimab) Group B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion

    Therapies Involved: Oncology: Neo-adjuvant; Oncology: 1st line; Oncology: 3rd line/Refractory

    ClinicalTrials.gov ID: NCT03005782

  • Objective

    The primary objectives in the dose escalation phase are to evaluate safety and pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of REGN3767 as monotherapy and in combination with cemiplimab in patients with advanced malignancies, including lymphoma.

    The primary objectives in the dose expansion phase are to assess preliminary anti-tumor activity of REGN3767 alone and in combination with cemiplimab (separately by cohort) as measured by objective response rate (ORR).

    NOTE: our site is only participating int the Dose Expansion portion of this study. **

  • Key Eligibility

    •  Dose escalation cohorts: Patients with histologically or cytologically confirmed diagnosis of malignancy (including lymphoma) with demonstrated progression of a tumor for whom there is no available therapy likely to convey clinical benefit AND who have not been previously treated with a PD-1/PD-L1 inhibitor. These patients do not require measurable disease
    •  Dose expansion cohorts: Patients with histologically or cytologically confirmed diagnosis of 1 of specified tumors with measurable disease per RECIST 1.1 or Lugano criteria. Some patients may have been previously treated with a PD-1 or PD-L1 inhibitor
    •  Eastern Cooperative Oncology Group performance status of 0 or 1
    •  Adequate organ and bone marrow function