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REGN3767

Phase 1

Malignancies | Small molecule | Oncology |Regeneron Pharmaceuticals, Inc.|Last Updated: May 1, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment333

FDA Designations

No designations recorded

Clinical trial landscape

REGN3767 · 1 trial · 1 indication

Phase 1 1
NCT03005782Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced CancersMalignancies
COMPLETED333 Analytics
PHASE1COMPLETED
Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers
Malignancies
NCT03005782333
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Study Endpoints

Primary Endpoints

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

Secondary Endpoints

Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase)
Baseline to week 51
Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase)
Baseline to week 51
Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase)
Baseline to 51 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Monotherapy (REGN3767)EXPERIMENTALGroup A will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition 1 tumor-specific cohort will be treated at the recommended phase 2 dose (RP2D) during dose expansion.
Combination Therapy (REGN3767+cemiplimab)EXPERIMENTALGroup B will consist of up to 4 sequential dose cohorts. Each cohort will receive 1 of 3 ascending dose levels of study drug during dose escalation. In addition, 9 tumor-specific cohorts will be treated at the RP2D during dose expansion

Interventions

NameTypeDescription
REGN3767DRUG -
cemiplimabDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites43

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 ...

Countries:United StatesAustraliaIrelandSouth KoreaUnited Kingdom
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Frequently asked questions about REGN3767

What is REGN3767 used for?

REGN3767 is an investigational small molecule being studied for the treatment of malignancies, which are cancers. It is currently in Phase 1 clinical development. The drug is being evaluated in patients with advanced cancers, as part of a study that also tests it in combination with another investigational therapy.

What does REGN3767 target?

REGN3767 is an anti-LAG-3 antibody, meaning it targets the LAG-3 protein, which is a checkpoint receptor on immune cells. By targeting LAG-3, the drug is designed to modulate the immune system's response to cancer cells. This mechanism is being studied in the context of advanced malignancies.

Who makes REGN3767?

REGN3767 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company. Regeneron is publicly traded under the ticker symbol REGN on the NASDAQ stock exchange. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is REGN3767 in?

REGN3767 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied in a Phase 1 trial to assess its safety, tolerability, and preliminary efficacy in patients with advanced cancers.

What clinical trials is REGN3767 in?

REGN3767 is being studied in one clinical trial with the identifier NCT03005782. This Phase 1 study, titled 'Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers,' has been completed. The trial enrolled 333 participants across multiple countries, including the United States, Australia, Ireland, South Korea, and the United Kingdom.

Is REGN3767 the same as REGN2810?

No, REGN3767 is not the same as REGN2810. REGN3767 is an anti-LAG-3 antibody, while REGN2810 is an anti-PD1 antibody. In the clinical trial NCT03005782, REGN3767 is being studied both alone and in combination with REGN2810 to evaluate their effects in patients with advanced cancers.