Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT06265727
Status:
RECRUITING
Last Update Posted:
2025-11-04
First Post:
2024-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Turkey (Türkiye)']}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711728', 'term': 'spartalizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'A three part study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 348}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-01-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2025-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: To confirm the safety and tolerability and determine MTD and PADR for CRB-701', 'timeFrame': '21 days', 'description': 'Occurrence of Dose Limiting Toxicities as defined in the protocol'}, {'measure': 'Part B & C: To evaluate efficacy in terms of Objective Response Rate (ORR)', 'timeFrame': 'Up to 6 months', 'description': 'ORR is the percentage of participants that achieve a response (CR + PR) using RECIST 1.1'}], 'secondaryOutcomes': [{'measure': 'Parts A, B, & C: To characterize the safety profile of CRB-701', 'timeFrame': 'Up to 6 months', 'description': 'Numbers of treatment emergent adverse events with severity determined using NCI CTCAE v5.0 after single or multiple doses of CRB-701 or single and multiple doses of CRB-701 and an anti-PD-(L)1 therapy'}, {'measure': 'Maximum observed plasma concentration of CRB-701 [total ADC] (Cmax)', 'timeFrame': 'Approximately 9 weeks', 'description': 'Maximum observed plasma concentration of total ADC after single and multiple doses'}, {'measure': 'Maximum observed plasma concentration of free MMAE (Cmax)', 'timeFrame': 'Approximately 9 weeks', 'description': 'Maximum observed plasma concentration of free MMAE after single and multiple doses'}, {'measure': 'Part B & C : To evaluate efficacy in terms of Disease Control Rate (DCR)', 'timeFrame': 'Up to 6 months', 'description': 'DCR is the sum of percentage of participants meeting the definition of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) for at least 4 months using RECIST 1.1'}, {'measure': 'Maximum observed plasma concentration of Total CRB-701 antibody [Tab] (Cmax)', 'timeFrame': 'Approximately 9 weeks', 'description': 'Maximum observed plasma concentration of free MMAE after single and multiple doses'}, {'measure': 'Time to reach Cmax of Total CRB-701 [Total ADC] (Tmax)', 'timeFrame': 'Approximately 9 weeks', 'description': 'The amount of time to reach Cmax after single and multiple dose administration of CRB-701 (Total ADC)'}, {'measure': 'Time to reach Cmax of free MMAE (Tmax)', 'timeFrame': 'Approximately 9 weeks', 'description': 'The amount of time to reach Cmax after single and multiple dose administration of free MMAE'}, {'measure': 'Time to reach Cmax of Total CRB-701 antibody [Tab] (Tmax)', 'timeFrame': 'Approximately 9 weeks', 'description': 'The amount of time to reach Cmax after single and multiple dose administration of Tab'}, {'measure': 'Time to reach Cmax of Total CRB-701 antibody [Tab] (Cmax)', 'timeFrame': 'Approximately 9 weeks', 'description': 'Maximum observed plasma concentration of free MMAE after single and multiple doses'}, {'measure': 'Total Area Under the plasma concentration-time curve of Total CRB-701 [total ADC] (AUC)', 'timeFrame': 'Approximately 9 weeks', 'description': 'Maximum observed plasma concentration of free MMAE after single and multiple doses'}, {'measure': 'Total Area Under the plasma concentration-time curve of free MMAE (AUC)', 'timeFrame': 'Approximately 9 weeks', 'description': 'Area under the plasma concentration versus time curve after single and multiple dose administration of free MMAE'}, {'measure': 'Total Area Under the plasma concentration-time curve of Total CRB-701 antibody [Tab] (AUC)', 'timeFrame': 'Approximately 9 weeks', 'description': 'Area under the plasma concentration versus time curve after single and multiple dose administration of Tab'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nectin-4'], 'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to define a safe and effective dose of CRB-701 for participants with solid tumors that are expressing a protein called nectin-4.\n\nThe main questions it aims to answer are:\n\nWhat is the the safe and effective dose of CRB-701 when used alone? What cancers can be treated effectively with CRB-701?\n\nParticipants will be asked to attend clinic and be given a intravenous infusion of CRB-701 on its own. They will have blood tests and other assessments to measure whether CRB-701 will have CT or MRI scans to measure the effect on tumors.', 'detailedDescription': "This is a three-part open-label, Phase 1/2 clinical trial designed to evaluate the safety, PK, and efficacy of CRB-701 in participants with advanced solid tumors expressing nectin-4.\n\nPart A will include solid tumor types known to express nectin-4. Dose escalation will be guided by the Bayesian optimal interval (BOIN) design to determine the MTD of CRB-701. Four (4) dose groups are pre-determined. Dose escalation/de-escalation decisions are made based on the occurrence of DLT.\n\nPart B will determine the RP2D of CRB-701 by evaluating two dose levels of CRB-701 alone and in combination with anti-PD-1 by using a time-to-event Bayesian optimal Phase 2 (TOP) study design to optimize the dose of CRB-701 in one or more separate cohorts of participants with nectin-4-positive tumors.\n\nDuring Part C, the RP2D dose of CRB-701 alone or combined with anti-PD-1 will be evaluated in five planned expansion cohorts using Simon's optimal two-stage design."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of select advanced or metastatic nectin-4 expressing solid tumors that have progressed following at least one line of therapy or have no other standard therapy with proven clinical benefit.\n\nExclusion Criteria:\n\n* Active of uncontrolled CNS metastases\n* History of solid tumors other than the diseases under study\n* History of and/or current cardiovascular events or conditions in the previous 6 months\n* Pre-existing \\>/= Grade 2 neuropathy\n* Hemoglobin A1C (HbA1C) \\>/= 8%, uncontrolled diabetes mellitus or know diabetic neuropathy\n* Active ocular disease at baseline\n* Chronic severe liver disease or live cirrhosis\n* Interstitial lung disease or pneumonitis within 6 months on initiating treatment on study\n* Other significant cormorbidities.'}, 'identificationModule': {'nctId': 'NCT06265727', 'briefTitle': 'A Phase 1/2 Study to Investigate CRB-701 in Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Corbus Pharmaceuticals Inc.'}, 'officialTitle': 'A Phase 1/2 Study to Investigate the Safety, Pharmacokinetics, and Efficacy of CRB-701, an Antibody-drug Conjugate Targeting Nectin-4, in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'CRB-701-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A Dose Escalation - CRB-701 Dose Level 1', 'description': 'CRB-701 Dose level 1, intravenous infusion over 30 mins, Dose schedule 1', 'interventionNames': ['Drug: CRB-701']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Dose Escalation - CRB-701 Dose Level 2', 'description': 'CRB-701 Dose Level 2, intravenous infusion over 30 mins, Dose schedule 1', 'interventionNames': ['Drug: CRB-701']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Dose Escalation - CRB-701 Dose Level 3', 'description': 'CRB-701 Dose Level 3, intravenous infusion over 30 mins, dose schedule 1', 'interventionNames': ['Drug: CRB-701']}, {'type': 'EXPERIMENTAL', 'label': 'Part A Dose Escalation - CRB-701 Dose Level 4', 'description': 'CRB-701 Dose Level 4, intravenous infusion over 30 mins, dose schedule 1', 'interventionNames': ['Drug: CRB-701']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Dose Optimization: CRB-701 High dose', 'description': 'Selected high dose of CRB-701, intravenous infusion over 30 mins, dose schedule 1', 'interventionNames': ['Drug: CRB-701']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Dose Optimization: CRB-701 low dose', 'description': 'Selected Low dose of CRB-701, intravenous infusion over 30 mins', 'interventionNames': ['Drug: CRB-701']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Dose Expansion - Cohort 1', 'description': 'Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1', 'interventionNames': ['Drug: CRB-701', 'Drug: Anti-PD-1']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Dose Expansion - Cohort 2', 'description': 'Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins', 'interventionNames': ['Drug: CRB-701']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Dose Expansion - Cohort 3', 'description': 'Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1', 'interventionNames': ['Drug: CRB-701', 'Drug: Anti-PD-1']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Dose Expansion - Cohort 4', 'description': 'Recommended Phase 2 dose of CRB-701 and schedule, intravenous infusion over 30 mins', 'interventionNames': ['Drug: CRB-701']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Dose Expansion - Cohort 5', 'description': 'Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1', 'interventionNames': ['Drug: CRB-701', 'Drug: Anti-PD-1']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1', 'description': 'Selected high dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1', 'interventionNames': ['Drug: CRB-701', 'Drug: Anti-PD-1']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1', 'description': 'Selected low dose of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1', 'interventionNames': ['Drug: CRB-701', 'Drug: Anti-PD-1']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Dose Expansion - Cohort 6', 'description': 'Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins', 'interventionNames': ['Drug: CRB-701']}, {'type': 'EXPERIMENTAL', 'label': 'Part C Dose Expansion - Cohort 7', 'description': 'Recommended Phase 2 dose and schedule of CRB-701, intravenous infusion over 30 mins followed by infusion with anti-PD-1', 'interventionNames': ['Drug: CRB-701', 'Drug: Anti-PD-1']}], 'interventions': [{'name': 'CRB-701', 'type': 'DRUG', 'description': 'Nectin-4 targeted Antibody Drug Conjugate (ADC)', 'armGroupLabels': ['Part A Dose Escalation - CRB-701 Dose Level 1', 'Part A Dose Escalation - CRB-701 Dose Level 2', 'Part A Dose Escalation - CRB-701 Dose Level 3', 'Part A Dose Escalation - CRB-701 Dose Level 4', 'Part B Dose Optimization: CRB-701 High dose', 'Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1', 'Part B Dose Optimization: CRB-701 low dose', 'Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1', 'Part C Dose Expansion - Cohort 1', 'Part C Dose Expansion - Cohort 2', 'Part C Dose Expansion - Cohort 3', 'Part C Dose Expansion - Cohort 4', 'Part C Dose Expansion - Cohort 5', 'Part C Dose Expansion - Cohort 6', 'Part C Dose Expansion - Cohort 7']}, {'name': 'Anti-PD-1', 'type': 'DRUG', 'description': 'checkpoint inhibitor', 'armGroupLabels': ['Part B Dose Optimization: CRB-701 high dose combined with anti-PD-1', 'Part B Dose Optimization: CRB-701 low dose combined with anti-PD-1', 'Part C Dose Expansion - Cohort 1', 'Part C Dose Expansion - Cohort 3', 'Part C Dose Expansion - Cohort 5', 'Part C Dose Expansion - Cohort 7']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Rodney Carter', 'role': 'CONTACT', 'email': 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Carter', 'role': 'CONTACT', 'email': 'clinical@corbuspharma.com'}], 'facility': "Institut de Cancerologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '94805', 'city': 'Villejuif', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Rodney Carter', 'role': 'CONTACT', 'email': 'clinical@corbuspharma.com'}], 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '50314', 'city': 'Florence', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rodney Carter', 'role': 'CONTACT', 'email': 'clinical@corbuspharma.com'}], 'facility': 'Careggi University Hospital', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20141', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rodney Carter', 'role': 'CONTACT', 'email': 'clinical@corbuspharma.com'}], 'facility': 'European Institute of Oncology IRCCS', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Carter', 'role': 'CONTACT', 'email': 'clinical@corbuspharma.com'}], 'facility': 'Fondazione Policlinico Gemelli, IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'zip': '37134', 'city': 'Verona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Rodney Carter', 'role': 'CONTACT', 'email': 'clinical@corbuspharma.com'}], 'facility': 'Centro Richerche Cliniche di Verona', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': 'MD-2025', 'city': 'Chisinau', 'status': 'RECRUITING', 'country': 'Moldova', 'facility': 'Institute of Oncology/ARENSIA Exploratory Medicine', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '22328', 'city': 'Bucharest', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Rodney Carter', 'role': 'CONTACT', 'email': 'clinical@corbuspharma.com'}], 'facility': 'Aresnsia Research Clinic Bucharest', 'geoPoint': {'lat': 44.43225, 'lon': 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