Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers
Status: | Recruiting |
---|---|
Conditions: | Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/20/2018 |
Start Date: | November 7, 2016 |
End Date: | March 29, 2022 |
Contact: | Clinical Trials Administrator |
Email: | clinicaltrials@regeneron.com |
Phone: | 844-734-6643 |
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
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 REGN2810 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 REGN2810
(separately by cohort) as measured by objective response rate (ORR).
pharmacokinetics (PK) in order to determine the selected dose level(s) for expansion of
REGN3767 as monotherapy and in combination with REGN2810 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 REGN2810
(separately by cohort) as measured by objective response rate (ORR).
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 may apply
We found this trial at
24
sites
801 University Boulevard Southeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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86 Jonathan Lucas Street
Charleston, South Carolina 29425
Charleston, South Carolina 29425
(843) 792-0700
Hollings Cancer Center at Medical University of South Carolina Located at the Medical University of...
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Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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11100 Euclid Avenue
Cleveland, Ohio 44087
Cleveland, Ohio 44087
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92 2nd St
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Washington, District of Columbia 20007
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