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

Study Purpose

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

- What side effects may happen from taking the study drug.

- How much study drug is in the blood at different times.

- Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

Dose-escalation cohorts: 1. Histologically or cytologically confirmed diagnosis of malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy. 2. Participants are required to submit archival tissue with optional fresh biopsy.Dose-expansion cohorts: 1. Histologically of cytologically confirmed diagnosis of Melanoma or ccRCC tumors with criteria, as defined in the protocol. 2. Participants are required to submit fresh pretreatment biopsy during screening.Key

Exclusion Criteria:

1. Prior treatment with Interleukin 2 (IL2)/IL15/IL7. 2. Prior treatment with anti PD-1/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 2 months prior to study therapy. 5. Has ongoing immune-related AEs prior to initiation of study drug, as defined in the protocol. 6. Has known allergy or hypersensitivity to components of the study drug. 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 drug. 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06413680
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Regeneron Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Clinical Trial Management
Principal Investigator Affiliation	Regeneron Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Melanoma, Clear-Cell Renal-Cell Carcinoma (ccRCC), Advanced Solid Tumors
Study Website:	View Trial Website

Additional Details

Phase 1: Conducted in the United States Phase 2: Conducted globally

Arms & Interventions

Arms

Experimental: Phase 1: Dose Escalation

Multiple dose level (DL) Cohorts to identify the recommended Phase 2 dose (RP2D)

Experimental: Phase 2: Dose Expansion

Cohort 1: Melanoma Participants Cohort 2: Clear-cell renal-cell carcinoma (ccRCC) participants

Interventions

Drug: - REGN10597

Administered as an intravenous (IV) infusion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Usc Norris Comprehensive Cancer Center, Los Angeles 5368361, California 5332921

Status

Recruiting

Address

Usc Norris Comprehensive Cancer Center

Los Angeles 5368361, California 5332921, 90033

Site Contact

[email protected]

844-734-6643

San Francisco 5391959, California 5332921

Status

Recruiting