Testing a New Immune-Boosting Cancer Drug (REGN10597) Alone or With Cemiplimab
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
In Plain English
This is an early-stage study testing a brand-new experimental drug called REGN10597 to see if it can help fight advanced cancers that have spread in the body. You may receive this drug by itself, or combined with another immune therapy drug called cemiplimab. The main goal is to figure out what dose is safe, what side effects happen, and whether the drug actually helps shrink tumors or slow cancer growth. This is a "first-in-human" study, which means REGN10597 has never been tested in patients before—only in the lab. The study has two phases: Phase 1 focuses on safety and finding the right dose (happening in the US), and Phase 2 expands to more patients worldwide to see if the drug actually works against cancer. Researchers will also check how long the drug stays in your blood and whether your immune system creates antibodies against it (which could affect how well it works). If you join, you'll have regular blood tests and imaging scans to monitor your health and how your cancer responds. This is a chance to access a cutting-edge treatment, but it also means accepting unknown risks since this drug is brand new in humans.
What This Trial Does
This study is researching an experimental drug called REGN10597 alone or in combination with another drug called cemiplimab (called "study drug(s)"). 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(s) are. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug(s) * How much study drug(s) is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)
How It Works
: Conducted in the United States only : Conducted globally
Who Can Join
- 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
- 2. 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
- 2. 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, and discontinuation 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.
Treatments
REGN10597 (DRUG)
Administered per the protocol
Cemiplimab (DRUG)
Administered per the protocol
Trial Sites (11)
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
RecruitingUniversity of California San Francisco (UCSF)
San Francisco, California, United States
RecruitingYale School of Medicine
North Haven, Connecticut, United States
RecruitingUniversity of Chicago
Chicago, Illinois, United States
RecruitingStart Midwest Cancer Research
Grand Rapids, Michigan, United States
RecruitingNorthwell Health
Lake Success, New York, United States
RecruitingUniversity of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
RecruitingUniversity of Pittsburgh Medical Center - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
RecruitingMD Anderson Cancer Center
Houston, Texas, United States
RecruitingNext Oncology
San Antonio, Texas, United States
RecruitingThe Start Center for Cancer Care
San Antonio, Texas, United States
Recruiting