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

Melanoma Clinical Trial

Official title:

A Phase 1/2a, Open-Label, Dose-Escalation and Dose-Expansion First-In-Human Study of the Safety, Tolerability, Activity, and Pharmacokinetics of REGN10597 (Anti PD-1-IL2RA-IL2 Fusion Protein) in Patients With Advanced Solid Organ Malignancies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06413680
• Other study ID #: R10597-ONC-22114
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: September 5, 2024
• Est. completion date: March 21, 2030

Study information

• Verified date: May 2024
• Source: Regeneron Pharmaceuticals
• Contact: Clinical Trials Administrator
• Phone: 844-734-6643
• Email: clinicaltrials[@]regeneron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: March 21, 2030
• Est. primary completion date: March 21, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Carcinoma, Renal Cell
• Melanoma
• Neoplasms

Intervention

Drug:
• REGN10597
Administered as an intravenous (IV) infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of dose-limiting toxicities (DLTs)		Up to Day 28
Primary	Incidence of treatment-emergent adverse event (TEAEs)		Approximately 6 Years
Primary	Incidence of serious adverse events (SAEs)		Approximately 6 Years
Primary	Incidence of TEAEs leading to treatment discontinuation		Approximately 6 Years
Primary	Incidence of TEAEs leading to death		Approximately 6 Years
Primary	Number of participants with Grade =3 laboratory abnormalities	Grade 3 or higher per Common terminology criteria for adverse events (CTCAE) version 5.0	Approximately 6 Years
Primary	Objective response rate (ORR) per response evaluation criteria in solid tumors (RECIST 1.1) criteria by investigator assessment	Dose-expansion	Approximately 6 Years
Secondary	ORR based on RECIST 1.1 criteria by investigator assessment	Dose-escalation	Approximately 6 Years
Secondary	Best overall response (BOR) based on RECIST 1.1 criteria		Approximately 6 Years
Secondary	Duration of response (DOR) based on RECIST 1.1 criteria		Approximately 6 Years
Secondary	Disease control rate based on RECIST 1.1		Approximately 6 Years
Secondary	Time to response based on RECIST 1.1		Approximately 6 Years
Secondary	Progression free survival (PFS) based on RECIST 1.1		Approximately 6 Years
Secondary	Concentrations of REGN10597 in serum		Approximately 6 Years
Secondary	Incidence of anti-drug antibody (ADA) to REGN10597 over time		Approximately 6 Years
Secondary	Titer of ADA to REGN10597 over time		Approximately 6 Years