Testing a new drug for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.