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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Regeneron Pharmaceuticals Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Regeneron Pharmaceuticals Inc

External identifiers

EU CT number

2025-523399-22-00

ClinicalTrials.gov

NCT06413680

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Safety

Dose escalation phase (only conducted in US): To evaluate safety of REGN10597 alone and in combination with cemiplimab
Dose expansion phase (conducted globally): To assess preliminary anti-tumor activity of REGN10597 alone and in combination with cemiplimab

Secondary objectives 3

1. To assess preliminary anti-tumor activity of REGN10597 alone and in combination with cemiplimab in dose escalation and dose expansion cohorts
2. To characterize the PK of REGN10597 alone and in combination with cemiplimab in dose escalation and dose expansion cohorts
3. To assess the immunogenicity of REGN10597 alone and in combination with cemiplimab in dose escalation and dose expansion cohorts

Conditions and MedDRA coding

Melanoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Adult participants ≥18 years of age
2. Dose escalation cohorts: 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
3. Dose expansion cohorts: Histologically of cytologically confirmed diagnosis of Melanoma or ccRCC tumors with criteria, as defined in the protocol. ALL participants ARE REQUIRED to submit fresh pretreatment biopsy during screening, with an additional exploratory biopsy at other time points
4. NOTE: Other Protocol Defined Inclusion Criteria Apply

Exclusion criteria 9

1. Prior treatment with Interleukin 2 (IL2)/IL15/IL7 given outside the context of concurrent administration with adoptive cell therapy
2. Prior treatment with anti PD-1/PD-L1 therapy, 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 drugs
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
9. NOTE: Other Protocol Defined Exclusion Criteria Apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Incidence of Dose-Limiting Toxicities (DLTs)
2. Incidence of Treatment-Emergent Adverse Event (TEAEs)
3. Incidence of Serious Adverse Events (SAEs)
4. Incidence of TEAEs leading to treatment discontinuation
5. Incidence of TEAEs leading to death
6. Number of participants with Grade ≥3 laboratory abnormalities
7. Objective Response Rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST 1.1) criteria by investigator assessment

Secondary endpoints 9

1. ORR based on RECIST 1.1 criteria by investigator assessment
2. Best Overall Response (BOR) based on RECIST 1.1 criteria
3. Duration Of Response (DOR) based on RECIST 1.1 criteria
4. Disease control rate based on RECIST 1.1
5. Time to response based on RECIST 1.1
6. Progression Free Survival (PFS) based on RECIST 1.1
7. Concentrations of REGN10597 in serum
8. Incidence of Anti-Drug Antibody (ADA) to REGN10597 over time
9. Magnitude of ADA to REGN10597 over time

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Regeneron Pharmaceuticals Inc.

Sponsor organisation

Regeneron Pharmaceuticals Inc.

Address

777 Old Saw Mill River Road

City

Tarrytown

Postcode

10591-6717

Country

United States

Scientific contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Public contact point

Organisation

Regeneron Pharmaceuticals Inc.

Contact name

Medical Affairs

Third parties 10

Locations

4 EU/EEA countries · 19 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 36 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications