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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
Recruiting
I'm InterestedTrial ID: NCT05125016
Purpose
This study is researching an investigational drug called REGN4336. Some participants may
receive additional investigational drugs in combination with REGN4336. These additional drugs
include REGN5678, cemiplimab and sarilumab.
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)?
Official Title
Phase 1/2 Study of REGN4336 (a PSMAxCD3 Bispecific Antibody) Administered Alone or in Combination With Cemiplimab or REGN5678 (a PSMAxCD28 Bispecific Antibody) in Patients With Metastatic Castration-Resistant Prostate Cancer
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
Key Inclusion Criteria:
1. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure
small cell carcinoma
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)
Key Exclusion Criteria:
1. Has received treatment with an approved systemic therapy within 3 weeks of dosing or
has not yet recovered (ie, grade ≤1 or baseline) from any acute toxicities
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.
NOTE: Other protocol defined Inclusion/Exclusion Criteria apply
Intervention(s):
drug: REGN4336
drug: Cemiplimab
drug: REGN5678
drug: Sarilumab
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Chidera Onwuka
650-721-4331