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No longer recruiting (closed or complete)Last updated: 2 February 2024

This phase I trial is evaluating the effectiveness and safety of a targeted therapy (REGN3767) alone and in combination with another targeted therapy (Cemiplimab) for the treatment of patients with advanced cancerA 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Multi-Cancer Multi-Cancer

Age

People18+

Clinical summary

Summary

Patients eligible to participate in this trial will receive either a specific dose of REGN3767 alone or specific dose of REGN3767 and cemiplimab.

Conditions

This trial is treating people with Advanced Cancer

Eligibility

Inclusion

  • 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

  • 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

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Regeneron Pharmaceuticals

Scientific 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

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