A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With Cemiplimab or REGN5678 for Adult Participants With Advanced Prostate Cancer
NCT ID: NCT05125016
Last Updated: 2025-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
370 participants
INTERVENTIONAL
2021-11-30
2027-01-14
Brief Summary
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The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug) and effectiveness of REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678. REGN4336, cemiplimab and REGN5678 are a type of treatment for cancer called immunotherapy,and are intended to activate T-cells to attack cancer cells.
This study has 2 parts. The purpose of Part 1 is to determine a safe dose of REGN4336 when given alone or when given in combination with cemiplimab or REGN5678. The purpose of Part 2 is to use the REGN4336 dose(s) determined in Part 1 to further test how well REGN4336 works to shrink tumors either when given alone or in combination with cemiplimab or REGN5678.
This study is looking at several other research questions, including:
* What side effects may happen from taking REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678?
* How much REGN4336 is in the blood at different times when it is given alone, in combination with cemiplimab, or in combination with REGN5678?
* Does the body make antibodies against the study drugs (REGN4336, cemiplimab, or REGN5678)?
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Module 1- Monotherapy
REGN4336
REGN4336
Administered once weekly (QW) by subcutaneous (SC) injection, or intravenous (IV) infusion
Sarilumab
Administered once by IV infusion as prophylaxis prior to REGN4336 IV
Module 2-Combo Therapy
REGN4336 + Cemiplimab
REGN4336
Administered once weekly (QW) by subcutaneous (SC) injection, or intravenous (IV) infusion
Cemiplimab
Administered concomitantly every 3 weeks (Q3W) by IV infusion
Sarilumab
Administered once by IV infusion as prophylaxis prior to REGN4336 IV
Module 3-Combo Therapy
REGN4336 + REGN5678
REGN4336
Administered once weekly (QW) by subcutaneous (SC) injection, or intravenous (IV) infusion
REGN5678
Administered concomitantly QW by IV infusion
Sarilumab
Administered once by IV infusion as prophylaxis prior to REGN4336 IV
Interventions
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REGN4336
Administered once weekly (QW) by subcutaneous (SC) injection, or intravenous (IV) infusion
Cemiplimab
Administered concomitantly every 3 weeks (Q3W) by IV infusion
REGN5678
Administered concomitantly QW by IV infusion
Sarilumab
Administered once by IV infusion as prophylaxis prior to REGN4336 IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Metastatic, castration-resistant prostate cancer (mCRPC) with PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening, according to 1 of the following:
1. PSA progression as defined by a rising PSA level confirmed with an interval of ≥1 week between each assessment
2. Radiographic disease progression in soft tissue based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria with or without PSA progression
3. Radiographic disease progression in bone defined as the appearance of 2 or more new bone lesions on bone scan with or without PSA progression NOTE: Measurable disease per RECIST version 1.1 per local reading at screening is not an eligibility criterion for enrollment
3. Has progressed upon or intolerant to ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to androgen deprivation therapy \[ADT\]) including at least one second-generation anti-androgen therapy (e.g. abiraterone, enzalutamide, apalutamide, or darolutamide)
Exclusion Criteria
2. Has received any previous systemic biologic or immune-modulating therapy (except for Sipuleucel-T) within 5 half-lives of first dose of study therapy, as described in the protocol
3. Has received prior PSMA-targeting therapy. Exception: Prior therapy with approved PSMA-targeted radioligand(s) is permitted
4. Any condition that requires ongoing/continuous corticosteroid therapy (\>10 mg prednisone/day or anti-inflammatory equivalent) within 1 week prior to the first dose of study therapy
5. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
6. Encephalitis, meningitis, neurodegenerative disease (with the exception of mild dementia that does not interfere with activities of daily living \[ADLs\]) or uncontrolled seizures in the year prior to first dose of study therapy
7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency, as described in the protocol.
18 Years
MALE
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Stanford University Medical Center - Blake Wilbur Drive
Palo Alto, California, United States
Norton Cancer Institute
Louisville, Kentucky, United States
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Atrium Health Levine Cancer Institute
Charlotte, North Carolina, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, United States
Penn Medicine University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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2022-502130-17-00
Identifier Type: OTHER
Identifier Source: secondary_id
R4336-ONC-20104
Identifier Type: -
Identifier Source: org_study_id
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