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Clinical Trials in the USA / NCT06413680
Recruiting Phase 1/2

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

NCT06413680 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 1/2
Started
2024-09-23
Last updated
2026-04-28

Condition(s) studied

MelanomaClear-Cell Renal-Cell Carcinoma (ccRCC)Advanced Solid Tumors

Investigational drug(s) / intervention(s)

REGN10597Cemiplimab

REGN10597: Administered per the protocol

Cemiplimab: Administered per the protocol

Study summary

This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). 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(s) are.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drug(s)
* How much study drug(s) is in the blood at different times
* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key 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: 1. Prior treatment with Interleukin 2 (IL2)/IL15/IL-7 given outside the context of concurrent administration with adoptive cell therapy 2. 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 3. Has received radiation therapy or major surgery within 14 days prior to first dose of study drug or has not yet recovered from AEs 4. 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 5. Has ongoing immune-related AEs prior to initiation of study intervention, as defined in the protocol 6. Has known allergy or hypersensitivity to components of the study drug(s) 7. 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 8. 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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
USC Norris Comprehensive Cancer Center Los Angeles California Recruiting
University of California San Francisco (UCSF) San Francisco California Recruiting
Yale School of Medicine North Haven Connecticut Recruiting
University of Chicago Chicago Illinois Recruiting
Start Midwest Cancer Research Grand Rapids Michigan Recruiting
Northwell Health Lake Success New York Recruiting
University of North Carolina at Chapel Hill Chapel Hill North Carolina Recruiting
University of Pittsburgh Medical Center - Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
MD Anderson Cancer Center Houston Texas Recruiting
Next Oncology San Antonio Texas Recruiting
The Start Center for Cancer Care San Antonio Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06413680 on ClinicalTrials.gov ↗ ← All trials in the USA