Summary

for people ages 18 years and up (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

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).

Official Title

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

Keywords

Malignancies Neoplasms Cemiplimab REGN3767 Monotherapy (REGN3767)

Eligibility

For people ages 18 years and up

Key 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

Key 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
  • Documented allergic or acute hypersensitivity reaction attributed to antibody treatments

Note: Other protocol defined Inclusion / Exclusion criteria apply

Locations

  • University of California Davis Health Systems accepting new patients
    Sacramento California 95817 United States
  • The Angeles Clinic accepting new patients
    Los Angeles California 90025 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
Links
Sign up for this study
ID
NCT03005782
Phase
Phase 1
Study Type
Interventional
Last Updated