Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2025-12-26 @ 11:46 AM
Study NCT ID:
NCT05125016
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2021-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627974', 'term': 'cemiplimab'}, {'id': 'C000592401', 'term': 'sarilumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study contains 3 separate modules in parallel: monotherapy with REGN4336 (Module 1) and combination therapies: REGN4336 plus cemiplimab (Module 2) and REGN4336 plus REGN5678 (Module 3). All 3 modules contain independent dose escalation cohorts and up to 2 recommended phase 2 dose regimens during dose expansion.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 370}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-01-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-08', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicities (DLTs)', 'timeFrame': '28 days, up to 42 days', 'description': 'Dose escalation'}, {'measure': 'Incidence and severity of treatment-emergent adverse events (TEAEs)', 'timeFrame': 'Up to 5 years', 'description': 'Dose escalation'}, {'measure': 'Incidence and severity of Immune-mediated Adverse Events (imAEs)', 'timeFrame': 'Up to 5 years', 'description': 'Dose escalation'}, {'measure': 'Incidence and severity of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 5 years', 'description': 'Dose escalation'}, {'measure': 'Incidence and severity of adverse event of special interest (AESIs)', 'timeFrame': 'Up to 5 years', 'description': 'Dose escalation'}, {'measure': 'Number of patients with grade ≥3 laboratory abnormalities', 'timeFrame': 'Up to 5 years', 'description': 'Dose escalation'}, {'measure': 'REGN4336 monotherapy concentrations in serum', 'timeFrame': 'Up to 5 years', 'description': 'Dose escalation'}, {'measure': 'REGN4336 concentrations in serum in combination with cemiplimab', 'timeFrame': 'Up to 5 years', 'description': 'Dose escalation'}, {'measure': 'REGN4336 concentrations in serum in combination with REGN5678', 'timeFrame': 'Up to 5 years', 'description': 'Dose escalation'}, {'measure': 'Objective response rate (ORR) per modified per modified Prostate Cancer Working Group 3 (PCWG3) criteria', 'timeFrame': 'Up to 5 years', 'description': 'Dose expansion'}], 'secondaryOutcomes': [{'measure': 'ORR per modified per modified PCWG3 criteria', 'timeFrame': 'Up to 5 years', 'description': 'Dose Escalation'}, {'measure': 'Incidence and severity of TEAEs', 'timeFrame': 'Up to 5 years', 'description': 'Dose expansion'}, {'measure': 'Incidence and severity of imAEs', 'timeFrame': 'Up to 5 years', 'description': 'Dose expansion'}, {'measure': 'Incidence and severity of SAEs', 'timeFrame': 'Up to 5 years', 'description': 'Dose expansion'}, {'measure': 'Incidence and severity of AESIs', 'timeFrame': 'Up to 5 years', 'description': 'Dose expansion'}, {'measure': 'Number of patients with grade ≥3 laboratory abnormalities', 'timeFrame': 'Up to 5 years', 'description': 'Dose expansion'}, {'measure': 'REGN4336 monotherapy concentrations in serum', 'timeFrame': 'Up to 5 years', 'description': 'Dose expansion'}, {'measure': 'REGN4336 concentrations in serum in combination with cemiplimab', 'timeFrame': 'Up to 5 years', 'description': 'Dose expansion'}, {'measure': 'REGN4336 concentrations in serum in combination with REGN5678', 'timeFrame': 'Up to 5 years', 'description': 'Dose expansion'}, {'measure': 'Percentage of patients with ≥50% reduction in prostate specific antigen (PSA) from baseline, confirmed by a second PSA test ≥3 weeks later', 'timeFrame': 'Up to 5 years', 'description': 'Dose escalation and expansion'}, {'measure': 'Percentage of patients with ≥90% reduction in PSA from baseline, confirmed by a second PSA test ≥3 weeks later', 'timeFrame': 'UP to 5 years', 'description': 'Dose escalation and expansion'}, {'measure': 'Anti-drug antibodies (ADA) to REGN4336', 'timeFrame': 'Up to 5 years', 'description': 'Module 1'}, {'measure': 'ADA to REGN4336 and cemiplimab', 'timeFrame': 'Up to 5 years', 'description': 'Module 2'}, {'measure': 'ADA to REGN4336 and REGN5678', 'timeFrame': 'Up to 5 years', 'description': 'Module 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Treatment-experienced metastatic castration-resistant prostate cancer (mCRPC)'], 'conditions': ['Metastatic Castration-resistant Prostate Cancer']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nThis 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.\n\nThis study is looking at several other research questions, including:\n\n* What side effects may happen from taking REGN4336 alone, in combination with cemiplimab, or in combination with REGN5678?\n* How much REGN4336 is in the blood at different times when it is given alone, in combination with cemiplimab, or in combination with REGN5678?\n* Does the body make antibodies against the study drugs (REGN4336, cemiplimab, or REGN5678)?'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma\n2. 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:\n\n 1. PSA progression as defined by a rising PSA level confirmed with an interval of ≥1 week between each assessment\n 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\n 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\n3. 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)\n\nKey Exclusion Criteria:\n\n1. 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\n2. 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\n3. Has received prior PSMA-targeting therapy. Exception: Prior therapy with approved PSMA-targeted radioligand(s) is permitted\n4. 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\n5. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments\n6. 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\n7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency, as described in the protocol.\n\nNOTE: Other protocol defined Inclusion/Exclusion Criteria apply'}, 'identificationModule': {'nctId': 'NCT05125016', 'briefTitle': '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', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'R4336-ONC-20104'}, 'secondaryIdInfos': [{'id': '2022-502130-17-00', 'type': 'OTHER', 'domain': 'EUCT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Module 1- Monotherapy', 'description': 'REGN4336', 'interventionNames': ['Drug: REGN4336', 'Drug: Sarilumab']}, {'type': 'EXPERIMENTAL', 'label': 'Module 2-Combo Therapy', 'description': 'REGN4336 + Cemiplimab', 'interventionNames': ['Drug: REGN4336', 'Drug: Cemiplimab', 'Drug: Sarilumab']}, {'type': 'EXPERIMENTAL', 'label': 'Module 3-Combo Therapy', 'description': 'REGN4336 + REGN5678', 'interventionNames': ['Drug: REGN4336', 'Drug: REGN5678', 'Drug: Sarilumab']}], 'interventions': [{'name': 'REGN4336', 'type': 'DRUG', 'description': 'Administered once weekly (QW) by subcutaneous (SC) injection, or intravenous (IV) infusion', 'armGroupLabels': ['Module 1- Monotherapy', 'Module 2-Combo Therapy', 'Module 3-Combo Therapy']}, {'name': 'Cemiplimab', 'type': 'DRUG', 'otherNames': ['REGN2810'], 'description': 'Administered concomitantly every 3 weeks (Q3W) by IV infusion', 'armGroupLabels': ['Module 2-Combo Therapy']}, {'name': 'REGN5678', 'type': 'DRUG', 'description': 'Administered concomitantly QW by IV infusion', 'armGroupLabels': ['Module 3-Combo Therapy']}, {'name': 'Sarilumab', 'type': 'DRUG', 'otherNames': ['REGN88', 'SAR153191'], 'description': 'Administered once by IV infusion as prophylaxis prior to REGN4336 IV', 'armGroupLabels': ['Module 1- Monotherapy', 'Module 2-Combo Therapy', 'Module 3-Combo Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Stanford University Medical Center - Blake Wilbur Drive', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Norton Cancer Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Maryland Greenebaum Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Rutgers Cancer Institute of New Jersey', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Atrium Health Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'The Ohio State University James Cancer Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Penn Medicine University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'centralContacts': [{'name': 'Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643'}], 'overallOfficials': [{'name': 'Clinical Trial Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.', 'ipdSharing': 'YES', 'description': 'All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing', 'accessCriteria': "Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf"}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}