Testing a new drug for advanced solid tumors

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-IL-2RA-IL-2 Fusion Protein) Alone or in Combination With Cemiplimab in Patients With Advanced Solid Organ Malignancies

This study is testing a new drug called REGN10597 to see if it is safe and effective for adults with advanced solid tumors like melanoma and kidney cancer.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Regeneron Pharmaceuticals (industry)
• Drugs / interventions: immunotherapy, radiation, prednisone, cemiplimab
• Locations: 11 sites (Los Angeles, California and 10 other locations)
• Trial ID: NCT06413680 on ClinicalTrials.gov

What this trial studies

This clinical trial is investigating the safety and effectiveness of an experimental drug called REGN10597 in adult patients with advanced solid organ malignancies, including melanoma and clear-cell renal-cell carcinoma. The study is divided into two phases, with Phase 1 focusing on dose-escalation to determine safety and tolerability, while Phase 2 will expand to a broader patient population globally. Participants will undergo assessments to monitor side effects, drug levels in the blood, and the body's immune response to the drug. Archival and fresh tissue samples will be collected to support the research.

Who should consider this trial

Good fit: Ideal candidates include adults with histologically confirmed advanced melanoma or clear-cell renal-cell carcinoma who have progressed on standard-of-care therapies.

Not a fit: Patients who have recently received certain immunotherapies or systemic therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that have not responded to standard therapies.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but this specific drug is being tested for the first time in humans.

Eligibility 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. 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 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, 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 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.

Where this trial is running

Los Angeles, California and 10 other locations

• USC Norris Comprehensive Cancer Center — Los Angeles, California, United States (RECRUITING)
• University of California San Francisco (UCSF) — San Francisco, California, United States (RECRUITING)
• Yale School of Medicine — North Haven, Connecticut, United States (RECRUITING)
• University of Chicago — Chicago, Illinois, United States (RECRUITING)
• Start Midwest Cancer Research — Grand Rapids, Michigan, United States (RECRUITING)
• Northwell Health — Lake Success, New York, United States (RECRUITING)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
• University of Pittsburgh Medical Center - Hillman Cancer Center — Pittsburgh, Pennsylvania, United States (RECRUITING)
• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
• Next Oncology — San Antonio, Texas, United States (RECRUITING)
• The Start Center for Cancer Care — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Clinical Trials Administrator

Conditions: Melanoma, Clear-Cell Renal-Cell Carcinoma, Advanced Solid Tumors, Advanced solid organ malignancies, Locally advanced, Metastatic, Non-uveal, Unresectable