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 (BrILliance)

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

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

Treatments: Drug: REGN10597; Drug: Cemiplimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT06413680

R10597-ONC-22114

2025-523399-22-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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)

Full description

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

Enrollment: 240 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 solid malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy
2. 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

2. 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, and discontinuation 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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240 participants in 4 patient groups

Phase 1: Monotherapy Dose Escalation

Experimental group

Description:

Multiple Dose Level (DL) Cohorts to identify the Recommended Phase 2 Dose (RP2D)

Treatment:

Drug: REGN10597

Phase 2: Monotherapy Dose Expansion

Experimental group

Description:

Cohort 1: Melanoma participants Cohort 2: Clear-cell Renal-Cell Carcinoma (ccRCC) participants

Treatment:

Drug: REGN10597

Phase 1: Combination Dose Escalation

Experimental group

Description:

Multiple DL Cohorts to identify the RP2D

Treatment:

Drug: Cemiplimab

Drug: REGN10597

Phase 2: Combination Dose Expansion

Experimental group

Description:

Cohort 1: Melanoma participants

Treatment:

Drug: Cemiplimab

Drug: REGN10597