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
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
Drug | Synonyms | Arms |
---|
REGN6569 | | REGN6569+cemiplimab |
Cemiplimab | REGN2810, Libtayo | REGN6569+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
Name | Type | Description | Interventions |
---|
REGN6569+cemiplimab | Experimental | REGN6569 lead-in | |
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. For
dose escalation only: Has received a COVID-19 vaccination within 1 week of planned
start of study medication or for which the planned COVID-19 vaccinations would not be
completed 1 week prior to start of study.
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
August 25, 2021