RECRUITING

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

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Conditions

MelanomaClear-Cell Renal-Cell Carcinoma (ccRCC)Advanced Solid TumorsAdvanced solid organ malignanciesLocally advancedMetastaticNon-uvealUnresectablePrimary or secondary resistance to programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

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

Quick Facts

Study Start:2024-09-23
Study Completion:2030-03-21
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06413680

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Histologically or cytologically confirmed diagnosis of malignancy (locally advanced or metastatic) with confirmed progression on standard-of-care therapy
  2. 2. Participants are required to submit archival tissue with optional fresh biopsy
  3. 1. Histologically of cytologically confirmed diagnosis of Melanoma or ccRCC tumors with criteria, as defined in the protocol
  4. 2. Participants are required to submit fresh pretreatment biopsy during screening
  1. 1. Prior treatment with Interleukin 2 (IL2)/IL15/IL7
  2. 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. 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. 4. Has had prior anti-cancer immunotherapy within 2 months prior to study therapy
  5. 5. Has ongoing immune-related AEs prior to initiation of study drug, as defined in the protocol
  6. 6. Has known allergy or hypersensitivity to components of the study drug
  7. 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. 8. Has ongoing or recent (within 5 years) evidence of significant autoimmune disease or any other condition that required treatment with systemic immunosuppressive treatments

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
START Midwest Cancer Research
Grand Rapids, Michigan, 49546
United States
The START Center for Cancer Care
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-23
Study Completion Date2030-03-21

Study Record Updates

Study Start Date2024-09-23
Study Completion Date2030-03-21

Terms related to this study

Keywords Provided by Researchers

  • Advanced solid organ malignancies
  • Locally advanced
  • Metastatic
  • Non-uveal
  • Unresectable
  • Primary or secondary resistance to programmed cell death protein 1 (PD-1)/ programmed cell death ligand 1 (PD-L1)

Additional Relevant MeSH Terms

  • Melanoma
  • Clear-Cell Renal-Cell Carcinoma (ccRCC)
  • Advanced Solid Tumors