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Trial Title:
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
NCT ID:
NCT06413680
Condition:
Melanoma
Clear-Cell Renal-Cell Carcinoma (ccRCC)
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Carcinoma, Renal Cell
Conditions: Keywords:
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)
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
REGN10597
Description:
Administered as an intravenous (IV) infusion
Arm group label:
Phase 1: Dose Escalation
Arm group label:
Phase 2: Dose Expansion
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)
Detailed description:
Phase 1: Conducted in the United States Phase 2: Conducted globally
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 5, 2024
Completion date:
March 21, 2030
Lead sponsor:
Agency:
Regeneron Pharmaceuticals
Agency class:
Industry
Source:
Regeneron Pharmaceuticals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06413680
