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Clinical trial

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

ID
Name
R3767-ONC-1613
Description
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).
Trial arms
Trial start
2016-11-07
Estimated PCD
2024-04-02
Trial end
2024-04-02
Status
Completed
Phase
Early phase I
Treatment
REGN3767
Arms:
Combination Therapy (REGN3767+cemiplimab), Monotherapy (REGN3767)
Other names:
fianlimab
cemiplimab
Arms:
Combination Therapy (REGN3767+cemiplimab)
Other names:
REGN2810
Size
333
Primary endpoint
Rate of dose limiting toxicities (Dose Escalation Phase)
Baseline to 28 days
Rate of adverse events (Dose Escalation Phase)
Baseline to 51 weeks
Rate of serious adverse events (Dose Escalation Phase)
Baseline to 51 weeks
Occurrence of death (Dose Escalation Phase)
Baseline to 51 weeks
Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Escalation Phase)
Baseline to 51 weeks
Area under the curve (AUC) computed from time zero to the time of the last concentration [AUCall] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
AUCall-to-dose ratio [AUCall/Dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
AUC from time zero extrapolated to infinity [AUCinf] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
AUCinf-to-dose ratio [AUCinf/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
AUC computed from time zero to the time of the last positive concentration [AUClast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
AUClast-to-dose ratio [AUClast/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Clearance [CL] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Maximum Plasma Concentration [Cmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to week 51
Cmax-to-dose ratio [Cmax/dose] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Last positive (quantifiable) concentration [Clast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Mean residence time extrapolated to infinity [MRTinf] (Dose Escalation Phase)
Baseline to 51 weeks
Mean residence time when the drug concentration profile is based on values up to and including the last positive concentration [MRTlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Observed terminal half-life [t1/2] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
t1/2 beta (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Time of the last positive (quantifiable) concentration [tlast] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Time to Cmax [tmax] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Volume of distribution at steady state [Vss] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Volume of distribution of the terminal phase [Vz] (Primary: Dose Escalation Phase; Secondary: Dose Expansion Phase)
Baseline to 51 weeks
Objective response rate based on RECIST 1.1 for Solid Tumors (Dose Expansion phase)
Baseline to 51 weeks
Objective response rate by Lugano criteria for Lymphoma (Dose Expansion Phase)
Baseline to 51 weeks
Eligibility criteria
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 Note: Other protocol defined Inclusion / Exclusion criteria apply
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 333, 'type': 'ACTUAL'}}
Updated at
2024-05-01

1 organization

2 products

3 abstracts

1 indication

Organization
Regeneron Pharmaceuticals
Product
REGN3767
Indication
Malignancy
Product
cemiplimab
Abstract
A phase 1 study of fianlimab (anti–LAG-3) in combination with cemiplimab (anti–PD-1) in patients with advanced HNSCC.
Org: Zuckerberg Cancer Center, Northwell Health Cancer Institute, Tallaght University Hospital,
Abstract
Significant durable response with fianlimab (anti-LAG-3) and cemiplimab (anti-PD-1) in advanced melanoma: Post adjuvant PD-1 analysis.
Org: The Angeles Clinic & Research Institute, A Cedars-Sinai Affiliate, Los Angeles, CA, Henry Ford Cancer Institute, Detroit, MI, START San Antonio, San Antonio, TX, University of Florida-Health Cancer Center, Orlando Health, Orlando, FL, MUSC Hollings Cancer Center, Charleston, SC,
Abstract
A phase 1 study of fianlimab (anti-LAG-3) in combination with cemiplimab (anti-PD-1) in patients with advanced melanoma: Poor-prognosis subgroup analysis.
Org: The Angeles Clinic & Research Institute, A Cedars-Sinai Affiliate, Los Angeles, CA, University of Colorado Cancer Center, Aurora, CO, USA, Henry Ford Cancer Institute, Detroit, MI, Sarah Cannon Research Institute, Tennessee Oncology, PLLC, Nashville, TN, START San Antonio, San Antonio, TX,