Clinical Trials /

Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers

NCT03005782

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).

Related Conditions:
  • Lymphoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of REGN3767 (Anti-LAG-3) With or Without REGN2810 (Anti-PD1) in Advanced Cancers
  • Official 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

Clinical Trial IDs

  • ORG STUDY ID: R3767-ONC-1613
  • SECONDARY ID: 2016-002789-30
  • NCT ID: NCT03005782

Conditions

  • Malignancies

Interventions

DrugSynonymsArms
REGN3767Monotherapy (REGN3767)
cemiplimabREGN2810Combination Therapy (REGN3767+cemiplimab)

Purpose

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

NameTypeDescriptionInterventions
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.
  • REGN3767
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
  • REGN3767
  • cemiplimab

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

          -  Documented allergic or acute hypersensitivity reaction attributed to antibody
             treatments

        Note: Other protocol defined Inclusion / Exclusion criteria apply
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Rate of dose limiting toxicities (Dose Escalation Phase)
Time Frame:Baseline to 28 days
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (solid tumors) (Dose Escalation Phase)
Time Frame:Baseline to week 51
Safety Issue:
Description:
Measure:Objective response rate per Lugano criteria (lymphomas) (Dose Escalation Phase)
Time Frame:Baseline to week 51
Safety Issue:
Description:
Measure:Best overall response based on RECIST 1.1 criteria (Dose Escalation Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Best overall response based on irRECIST criteria (Dose Escalation Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Best overall response based on Lugano criteria (Dose Escalation Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Duration of response based on RECIST criteria (Dose Escalation Phase)
Time Frame:Baseline to week 51
Safety Issue:
Description:
Measure:Duration of response based on irRECIST criteria (Dose Escalation Phase)
Time Frame:Baseline to week 51
Safety Issue:
Description:
Measure:Duration of response based on Lugano criteria (Dose Escalation Phase)
Time Frame:Baseline to week 51
Safety Issue:
Description:
Measure:Disease control rate based on RECIST criteria (Dose Escalation Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Disease control rate based on irRECIST criteria (Dose Escalation Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Disease control rate based on Lugano criteria (Dose Escalation Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Progression free survival based on RECIST (Dose Escalation Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Progression free survival based on irRECIST (Dose Escalation Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Progression free survival based on Lugano criteria (Dose Escalation Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Incidence of adverse events (Dose Expansion Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Incidence of serious adverse events (Dose Expansion Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Incidence of death (Dose Expansion Phase)
Time Frame:From Baseline to the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 42 months
Safety Issue:
Description:
Measure:Number of patients with laboratory abnormalities (grade 3 or higher per Common Terminology Criteria for Adverse Events [CTCAE]) (Dose Expansion Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:
Measure:Incidence of anti-drug antibodies (Dose Escalation Phase and Dose Expansion Phase)
Time Frame:Baseline to 51 weeks
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Regeneron Pharmaceuticals

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