R3767-ONC-1613: 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
Primary Objective in the Dose Escalation Phase:
To evaluate safety and PK in order to determine an RP2D of REGN3767 as monotherapy and in combination with REGN2810 on patients with advanced malignancies, including lymphoma.
Primary Objective in the Dose Expansion Phase:
To assess preliminary anti-tumor activity of REGN3767 alone and in combination with REGN2810 (separately by cohort) as measured by ORR.
Chemotherapy single agent systemic
- Rutgers Cancer Institute of New Jersey
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
- 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
- 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
Note: Other protocol defined Inclusion / Exclusion criteria apply
Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.
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