NCT06413680 · Regeneron Pharmaceuticals
A First-In Human (FIH) Trial to Find Out if REGN10597 is Safe and How Well it Works for Adult Participants With Advanced Solid Organ Malignancies
What this study is about
This study is researching an experimental drug called REGN10597 (called "study drug"). The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the study drug is.
View original scientific description
This study is researching an experimental drug called REGN10597 (called "study drug"). The study is focused on patients with certain solid tumors that are in an advanced stage. The aim of the study is to see how safe, tolerable, and effective the study drug is.
Interventions
DRUG
REGN10597
Administered per the protocol
DRUG
Cemiplimab
Administered per the protocol
Primary outcome measures
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: Up to Day 29
Dose escalation
Incidence of Treatment-Emergent Adverse Event (TEAEs)
Time frame: Approximately 6 Years
Dose escalation
Incidence of Serious Adverse Events (SAEs)
Time frame: Approximately 6 Years
Dose escalation
Incidence of TEAEs leading to treatment discontinuation
Time frame: Approximately 6 Years
Dose escalation
Incidence of TEAEs leading to death
Time frame: Approximately 6 Years
Dose escalation
Number of participants with Grade 3 laboratory abnormalities
Time frame: Approximately 6 Years
Dose escalation Grade 3 or higher per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment
Time frame: Approximately 6 Years
Dose expansion
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Dose escalation cohorts: 1\. 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: 1\. Histologically of cytologically confirmed diagnosis of one of the following tumors with criteria, as defined in the protocol:
- Module 1, Cohort 1: anti-PD-(L)1 Progressed Melanoma or
- Module 1, Cohort 2: anti-PD-(L)1 Progressed RCC or
- Module 2, Cohort 1: 1L Melanoma ALL Participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points Key
Exclusion criteria
- Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy
- Prior treatment with anti-PD1/PD-L1, 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 drug(s)
- 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 Inclusion / Exclusion Criteria Apply.
Where
- Los Angeles, California
- San Francisco, California
- North Haven, Connecticut
- Chicago, Illinois
- Grand Rapids, Michigan
- Lake Success, New York
- Chapel Hill, North Carolina
- Pittsburgh, Pennsylvania
- Houston, Texas
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 28, 2026 · Source of record for eligibility and locations