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

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Melanoma; Advanced Solid Tumors; Clear-Cell Renal-Cell Carcinoma (ccRCC)

Treatments: Drug: REGN10597

Study type: Interventional

Funder types: Industry

Identifiers

NCT06413680

R10597-ONC-22114

Details and patient eligibility

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.

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)

Full description

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

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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 design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Phase 1: Dose Escalation

Experimental group

Description:

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

Treatment:

Drug: REGN10597

Phase 2: Dose Expansion

Experimental group

Description:

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

Treatment:

Drug: REGN10597