Clinical Trials /

Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

NCT04465487

Description:

For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab. For dose expansion cohorts, the co-primary objectives are: - To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by objective response rate (ORR) - To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy, as measured by intratumoral Glucocorticoid-Induced Tumor necrosis factor receptor-Related (GITR)+ Treg depletion Secondary Objectives are: For dose escalation cohorts: - To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by ORR, disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with cemiplimab - To assess the immunogenicity of REGN6569 and cemiplimab For expansion cohorts: - To characterize the safety profile in each expansion cohort - To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by DCR, DOR, PFS, and OS - To characterize the PK of REGN6569 alone and in combination with cemiplimab - To assess the immunogenicity of REGN6569 and cemiplimab

Related Conditions:
  • Head and Neck Squamous Cell Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies
  • Official Title: A Phase 1 Study of REGN6569, an Anti-GITR mAb, With Cemiplimab in Patients With Advanced Solid Tumor Malignancies

Clinical Trial IDs

  • ORG STUDY ID: R6569-ONC-1933
  • SECONDARY ID: 2020-000075-20
  • NCT ID: NCT04465487

Conditions

  • Squamous Cell Carcinoma of Head and Neck

Interventions

DrugSynonymsArms
REGN6569REGN6569+cemiplimab
CemiplimabREGN2810, LibtayoREGN6569+cemiplimab

Purpose

For dose escalation cohorts, the primary objective is to evaluate the safety and tolerability of REGN6569 as monotherapy lead-in and in combination with cemiplimab. For dose expansion cohorts, the co-primary objectives are: - To assess the preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by objective response rate (ORR) - To assess the preliminary pharmacodynamic activity of REGN6569 as lead-in monotherapy, as measured by intratumoral Glucocorticoid-Induced Tumor necrosis factor receptor-Related (GITR)+ Treg depletion Secondary Objectives are: For dose escalation cohorts: - To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by ORR, disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) - To characterize the pharmacokinetics (PK) of REGN6569 alone and in combination with cemiplimab - To assess the immunogenicity of REGN6569 and cemiplimab For expansion cohorts: - To characterize the safety profile in each expansion cohort - To assess preliminary efficacy of REGN6569 in combination with cemiplimab, as measured by DCR, DOR, PFS, and OS - To characterize the PK of REGN6569 alone and in combination with cemiplimab - To assess the immunogenicity of REGN6569 and cemiplimab

Trial Arms

NameTypeDescriptionInterventions
REGN6569+cemiplimabExperimentalREGN6569 lead-in
  • REGN6569
  • Cemiplimab

Eligibility Criteria

        Key Inclusion Criteria:

          1. Dose escalation cohorts: Advanced stage (unresectable or metastatic) solid tumor
             malignancy, confirmed histologically or cytologically as defined in the protocol

          2. Dose expansion cohorts: Advanced stage (unresectable or metastatic) head and neck
             squamous cell carcinoma, confirmed histologically or cytologically as defined in the
             protocol

          3. Mandatory biopsies: Able and willing to provide tumor tissue at baseline and while on
             treatment, with at least 1 soft tissue lesion amenable to biopsy by ultrasound or
             computed tomography (CT)-guided biopsy

             All Cohorts:

          4. Has no prior history of immune checkpoint blockade (ICB) therapy

          5. Has exhausted all approved available treatment options for their disease, with no
             standard therapy likely to convey clinical benefit as defined in the protocol

        Key Exclusion Criteria:

          1. Has previously received GITR-targeted therapy

          2. Has received any previous systemic biologic therapy within 5 half-lives of first dose
             of study therapy as defined in the protocol

          3. Has any condition that requires ongoing/continuous corticosteroid therapy (>10 mg
             prednisone/day or anti-inflammatory equivalent) within 14 days prior to the first dose
             of study therapy

          4. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease that
             required treatment with systemic immunosuppressive treatments as defined in the
             protocol

          5. Has a known history of, or any evidence of, interstitial lung disease, or active,
             non-infectious pneumonitis in the past 5 years. A history of radiation pneumonitis in
             the radiation field is permitted as long as pneumonitis resolved ≥6 months prior to
             first dose of study therapy

          6. Has uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis
             C infection, or diagnosis of immunodeficiency

          7. Has received a live vaccine within 4 weeks of planned start of study medication

          8. Has had prior allogeneic stem cell transplantation or received organ transplants at
             any time, or autologous stem cell transplantation

        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:Incidence of dose-limited toxicities (DLTs)
Time Frame:Up to 42 days
Safety Issue:
Description:Dose escalation period

Secondary Outcome Measures

Measure:ORR
Time Frame:Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Safety Issue:
Description:Dose escalation period
Measure:Disease control rate (DCR)
Time Frame:Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Safety Issue:
Description:Dose escalation and expansion periods
Measure:Duration of Response (DOR)
Time Frame:Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Safety Issue:
Description:Dose escalation and expansion periods
Measure:Progression-free Survival (PFS)
Time Frame:Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Safety Issue:
Description:Dose escalation and expansion periods
Measure:Overall survival (OS)
Time Frame:Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Safety Issue:
Description:Dose escalation and expansion periods
Measure:Drug concentrations of REGN6569 in serum
Time Frame:Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Safety Issue:
Description:Dose escalation and expansion periods
Measure:Drug concentrations of cemiplimab in serum
Time Frame:Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Safety Issue:
Description:Dose escalation and expansion periods
Measure:Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569
Time Frame:Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Safety Issue:
Description:Dose escalation and expansion periods
Measure:Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab
Time Frame:Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months
Safety Issue:
Description:Dose escalation and expansion periods

Details

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

Trial Keywords

  • Unselected solid tumors dose escalation
  • HNSCC dose expansion
  • Advanced stage solid tumor malignancy
  • Unresectable
  • Metastatic

Last Updated

October 14, 2020