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A First-In-Human (FIH) Study to Find Out How Well REGN10597 Medicine Given Alone or in Combination with Cemiplimab Works in Adult Participants Who Have Cancer with Tumors that Have Spread in Their Body
EU CTIS ID: 2025-523399-22-00
What this study is testing
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
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.