Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Prior treatment with any LAG-3 targeting biologic or small molecule - Radiation therapy within 2 weeks prior to randomization and not recovered to baseline from any AE due to radiation - Untreated or active central nervous system metastases - Ongoing or recent (within 5 years) evidence of significant autoimmune disease - Corticosteroid therapy (>10 mg prednisone/day or equivalent) within 1 week prior to the first dose of study drug - Myocardial infarction within 6 months Note: Other protocol defined Inclusion / Exclusion criteria apply

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: REGN3767
    Other names:
    • fianlimab
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
  • Drug: REGN3767
    Other names:
    • fianlimab
  • Drug: cemiplimab
    Other names:
    • REGN2810

More Details

Status
Active, not recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.