A Phase 1/2a, Open-Label, Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti PD-1-IL2RA-IL2 Fusion Protein) Alone or in Combination with Cemiplimab in Patients with Advanced Solid Organ Malignancies
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 99
- Locations
- 19
- Primary Endpoint
- Incidence of Serious Adverse Events (SAEs)
Study Overview
Brief Summary
Dose escalation phase (only conducted in US): To evaluate safety of REGN10597 alone and in combination with cemiplimab Dose expansion phase (conducted globally): To assess preliminary anti-tumor activity of REGN10597 alone and in combination with cemiplimab
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult participants ≥18 years of age
- •Dose escalation cohorts: Histologically or cytologically confirmed diagnosis of solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. Participants are required to submit archival tissue if it is available
- •Dose expansion cohorts: Histologically of cytologically confirmed diagnosis of Melanoma or ccRCC tumors with criteria, as defined in the protocol. ALL participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points
- •NOTE: Other Protocol Defined Inclusion Criteria Apply
Exclusion Criteria
- •Prior treatment with Interleukin 2 (IL2)/IL15/IL7 given outside the context of concurrent administration with adoptive cell therapy
- •Prior treatment with anti PD-1/PD-L1 therapy, or an approved systemic therapy or any previous systemic non-immunomodulatory biologic therapy within 4 weeks, as defined in the protocol
- •Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs
- •Has had prior anti-cancer immunotherapy within 4 weeks prior to study intervention, or discontinuation of prior anti-cancer immunotherapy due to grade 3 or 4 toxicities
- •Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol
- •Has known allergy or hypersensitivity to components of the study drugs
- •Has any condition requiring ongoing/continuous corticosteroid therapy (>10 mg prednisone/day or anti-inflammatory equivalent) within 1-2 weeks to the first dose of study intervention
- •Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments
- •NOTE: Other Protocol Defined Exclusion Criteria Apply
Arms & Interventions
LIBTAYO 350 mg concentrate for solution for infusion., LIBTAYO 350 mg concentrate for solution for infusion., LIBTAYO 350 mg concentrate for solution for infusion., LIBTAYO 350 mg concentrate for solution for infusion.
Intervention: LIBTAYO 350 mg concentrate for solution for infusion. (Drug)
REGN10597
Intervention: REGN10597 (Drug)
Outcomes
Primary Outcomes
Incidence of Serious Adverse Events (SAEs)
Incidence of Serious Adverse Events (SAEs)
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence of Dose-Limiting Toxicities (DLTs)
Incidence of Treatment-Emergent Adverse Event (TEAEs)
Incidence of Treatment-Emergent Adverse Event (TEAEs)
Incidence of TEAEs leading to treatment discontinuation
Incidence of TEAEs leading to treatment discontinuation
Incidence of TEAEs leading to death
Incidence of TEAEs leading to death
Number of participants with Grade ≥3 laboratory abnormalities
Number of participants with Grade ≥3 laboratory abnormalities
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment
Secondary Outcomes
- ORR based on RECIST 1.1 criteria by investigator assessment
- Best Overall Response (BOR) based on RECIST 1.1 criteria
- Duration Of Response (DOR) based on RECIST 1.1 criteria
- Disease control rate based on RECIST 1.1
- Time to response based on RECIST 1.1
- Progression Free Survival (PFS) based on RECIST 1.1
- Concentrations of REGN10597 in serum
- Incidence of Anti-Drug Antibody (ADA) to REGN10597 over time
- Magnitude of ADA to REGN10597 over time
Investigators
Medical Affairs
Scientific
Regeneron Pharmaceuticals Inc.