Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
Study NCT ID:
NCT03972657
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2019-05-30
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627974', 'term': 'cemiplimab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 345}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-05', 'studyFirstSubmitDate': '2019-05-30', 'studyFirstSubmitQcDate': '2019-05-30', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation Phase'}, {'measure': 'Incidence and severity of Adverse Event of Special Interests (AESIs)', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation Phase'}, {'measure': 'Incidence and severity of Serious Adverse Events (SAEs)', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation Phase'}, {'measure': 'Number of participants with Grade ≥3 laboratory abnormalities', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation Phase'}, {'measure': 'Incidence of Dose-Limiting Toxicities (DLTs)', 'timeFrame': 'First dose through day 42 of last participant in each dose level', 'description': 'Dose Escalation Phase'}, {'measure': 'Concentration of REGN5678 in serum over time', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation Phase'}, {'measure': 'Concentration of REGN5678 in combination with cemiplimab in serum over time', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation Phase'}, {'measure': 'Composite Response Rate (CRR) of 50% decline of Prostate Specific Antigen (PSA) and/or confirmed radiographic response of complete (CR) or partial response (PR)', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Expansion Phase - mCRPC cohort'}, {'measure': 'Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Expansion Phase - ccRCC cohort'}], 'secondaryOutcomes': [{'measure': 'CRR of 50% decline of PSA and/or confirmed radiographic of CR or PR', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation Phase - mCRPC cohort'}, {'measure': 'ORR per RECIST 1.1 criteria', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation Phase - ccRCC cohort'}, {'measure': 'Incidence and severity of TEAEs', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Expansion Phase'}, {'measure': 'Incidence and severity of AESIs', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Expansion Phase'}, {'measure': 'Incidence and severity of SAEs', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Expansion Phase'}, {'measure': 'Number of participants with grade ≥3 laboratory abnormalities', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Expansion Phase'}, {'measure': 'Concentration of REGN5678 in serum over time', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Expansion Phase'}, {'measure': 'Concentration of REGN5678 in combination with cemiplimab in serum over time', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Expansion Phase'}, {'measure': 'Percentage of participants with ≥50% decline of PSA', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation and Dose Expansion Phases - mCRPC cohorts'}, {'measure': 'Percentage of participants with ≥90% decline of PSA', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation and Dose Expansion Phases- mCRPC cohorts'}, {'measure': 'Presence or absence of antibodies against REGN5678', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation and Dose Expansion Phases'}, {'measure': 'Presence or absence of antibodies against cemiplimab', 'timeFrame': 'Through study completion, up to 5 years', 'description': 'Dose Escalation and Dose Expansion Phases'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Castration-Resistant Prostate Cancer (mCRPC)', 'Clear Cell Renal Cell Carcinoma (ccRCC)']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\\[s\\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab.\n\nThe study has 2 parts. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab. The goal of Part 2 (dose expansion) is to use the REGN5678 drug dose(s) found in Part 1 to see how well REGN5678 alone or in combination with cemiplimab works to shrink tumors.\n\nThis study is looking at several other research questions, including:\n\n1. Side effects that may be experienced by taking REGN5678 alone or in combination with cemiplimab\n2. How REGN5678 alone or in combination with cemiplimab works in the body\n3. How much REGN5678 and/or cemiplimab are present in the blood\n4. To see if REGN5678 alone or in combination with cemiplimab works to reduce the size of the tumor by helping the immune system destroy the tumor'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\nmCRPC cohorts (men):\n\n1. Men with histologically or cytologically confirmed adenocarcinoma of the prostate without pure small cell carcinoma.\n2. PSA value at screening ≥4 ng/mL that has progressed within 6 months prior to screening as defined in the protocol.\n3. Has received ≥2 lines prior systemic therapy approved in the metastatic and/or castration-resistant setting (in addition to Androgen Deprivation Therapy \\[ADT\\]) including at least:\n\n 1. one second-generation anti-androgen therapy (eg, abiraterone, enzalutamide, apalutamide, or darolutamide)\n 2. 177Lu-PSMA-617 radiotherapy, or another lutetium-based PSMA targeted radioligand, as described in the protocol\n\nccRCC cohorts (men and women):\n\n1. Histologically or cytologically confirmed RCC with a clear-cell component.\n2. Diagnosis of metastatic ccRCC with at least one measurable lesion via RECIST 1.1 criteria\n3. Has progressed on or after ≥1 line prior systemic therapy approved in the metastatic setting. Prior treatment must include an anti-Programmed Death-1 (receptor) \\[PD-1\\]/Programmed Death-Ligand 1 (PD-L1) therapy and either ipilimumab and/or a tyrosine kinase inhibitor\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, as described in the protocol\n2. Has received any previous systemic biologic therapy within 5 half-lives of first dose of study therapy, as described in the protocol\n3. Has received prior PSMA-targeting therapy with the exception of a PSMA targeting radioligand (eg. 177Lu-PSMA-617) in mCRPC\n4. Dose Escalation: Has had prior anti-cancer immunotherapy (other than sipuleucel-T) within 5 half-lives prior to study therapy.\n5. Dose Expansion (mCRPC only): Has had prior anti-cancer immunotherapy, as described in the protocol\n6. 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\n7. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, as described in the protocol\n8. 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\n9. Uncontrolled infection with Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency\n\nNOTE: Other protocol defined Inclusion/Exclusion Criteria apply'}, 'identificationModule': {'nctId': 'NCT03972657', 'briefTitle': 'A Trial to Find Out if REGN5678 (Nezastomig) is Safe and How Well it Works Alone or in Combination With Cemiplimab for Adult Participants With Metastatic Castration-Resistant Prostate Cancer and Other Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Phase 1/2 Study of REGN5678 (Anti-PSMAxCD28) With or Without Cemiplimab (Anti-PD-1) in Patients With Metastatic Castration-Resistant Prostate Cancer and Other Tumors Associated With PSMA Expression', 'orgStudyIdInfo': {'id': 'R5678-ONC-1879'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mCRPC - dose escalation cohort', 'description': 'REGN5678 with or without cemiplimab', 'interventionNames': ['Drug: REGN5678', 'Drug: Cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'mCRPC - dose expansion cohort', 'description': 'REGN5678 with or without cemiplimab', 'interventionNames': ['Drug: REGN5678']}, {'type': 'EXPERIMENTAL', 'label': 'ccRCC - dose escalation cohort', 'description': 'REGN5678 with or without cemiplimab', 'interventionNames': ['Drug: REGN5678', 'Drug: Cemiplimab']}, {'type': 'EXPERIMENTAL', 'label': 'ccRCC - dose expansion cohort', 'description': 'REGN5678 with or without cemiplimab', 'interventionNames': ['Drug: REGN5678']}], 'interventions': [{'name': 'REGN5678', 'type': 'DRUG', 'otherNames': ['Nezastomig'], 'description': 'Administered as per the protocol', 'armGroupLabels': ['ccRCC - dose escalation cohort', 'ccRCC - dose expansion cohort', 'mCRPC - dose escalation cohort', 'mCRPC - dose expansion cohort']}, {'name': 'Cemiplimab', 'type': 'DRUG', 'otherNames': ['REGN2810', 'LIBTAYO'], 'description': 'Administered as per the protocol', 'armGroupLabels': ['ccRCC - dose escalation cohort', 'mCRPC - dose escalation cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'John Wayne Cancer Institute (JWCI)', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute (SCRI)', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Yale University Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Moffitt Cancer Center - McKinley Drive', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'NYU Langone Health Perlmutter Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Columbia University - The Trustees of Columbia University in the City of New York', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center) - Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '97213', 'city': 'Portland', 'state': 'Oregon', 'status': 'WITHDRAWN', 'country': 'United States', 'facility': 'Providence Portland Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Oregon Health & Science University (3485 S. Bond)', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Lifespan Cancer Institute', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Emily Couric Clinical Cancer Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'Clinical Trials Administrator', 'role': 'CONTACT', 'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643'}], 'overallOfficials': [{'name': 'Clinical Trials Management', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Regeneron Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'url': 'https://vivli.org/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'When Regeneron has:\n\n* 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 or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development\n* made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)\n* the legal authority to share the data, and\n* 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'}}}}