Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-01 @ 2:06 AM
Study NCT ID:
NCT07123103
Status:
RECRUITING
Last Update Posted:
2025-10-30
First Post:
2025-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2025-08-08', 'studyFirstSubmitQcDate': '2025-08-08', 'lastUpdatePostDateStruct': {'date': '2025-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with a Dose-limiting Toxicity (DLT)', 'timeFrame': 'Up to the end of the first cycle (Up to Day 21 of a 21-day cycle)'}, {'measure': 'Number of Participants with a Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'Up to approximately 7 months'}], 'secondaryOutcomes': [{'measure': 'Area Under the Plasma Concentration-time Curve (AUC) of XB371, Total Antibody and Unconjugated Belotecan', 'timeFrame': 'Up to approximately 7 months'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax) of XB371, Total Antibody and Unconjugated Belotecan', 'timeFrame': 'Up to approximately 7 months'}, {'measure': 'Time to Maximum Observed Plasma Concentration (Tmax) of XB371, Total Antibody and Unconjugated Belotecan', 'timeFrame': 'Up to approximately 7 months'}, {'measure': 'Trough Observed Plasma Concentration (Ctrough) of XB371, Total Antibody and Unconjugated Belotecan', 'timeFrame': 'Up to approximately 7 months'}, {'measure': 'Number of Participants with Antidrug Antibodies to XB371', 'timeFrame': 'Up to approximately 7 months'}, {'measure': 'Dose-escalation Cohorts Only: Recommended Dose(s) for Expansion', 'timeFrame': 'Through completion of dose-escalation (up to approximately 18 months)'}, {'measure': 'Dose-expansion Cohorts Only: Objective Response Rate as Assessed by the Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)', 'timeFrame': 'Up to approximately 18 months'}, {'measure': 'Dose-expansion Cohorts Only: Duration of Response as Assessed by the Investigator per RECIST v1.1', 'timeFrame': 'Up to approximately 18 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Solid Tumors', 'Metastatic Solid Tumors'], 'conditions': ['Solid Tumors']}, 'descriptionModule': {'briefSummary': 'The primary purpose of the study is to characterize the safety and tolerability of XB371. The dose-escalation cohorts and Part B of the expansion cohorts are non-randomized. Part A of the expansion cohorts is randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.\n* Minimum life expectancy of ≥ 12 weeks.\n* Recurrent locally advanced or metastatic solid tumors.\n* Adequate end organ and bone marrow function.\n\nKey Exclusion Criteria:\n\n* Primary brain tumors or known active brain metastases, leptomeningeal, or cranial epidural disease.\n* History of interstitial lung disease (ILD) of any grade or history of organizing pneumonia.\n* Has acute ocular infection, acute or chronic ulcerative/cicatricial condition of conjunctiva or cornea.\n* Known history of immunodeficiency virus (HIV) unless specific criteria are met.\n* Active infection with hepatitis C virus (HCV) defined as positive for HCV antibody.\n* Major surgery within 4 weeks before the first dose of study treatment.\n* Received radiation therapy within 2 weeks before the first dose of study treatment.\n* Received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study treatment.\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07123103', 'briefTitle': 'A Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Exelixis'}, 'officialTitle': 'A Dose Escalation and Expansion Study of XB371 Administered in Participants With Locally Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'XB371-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose-escalation Cohorts', 'description': 'Participants will receive escalating doses of XB371 every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.', 'interventionNames': ['Drug: XB371']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-expansion Cohorts: Part A', 'description': 'Participants with Tumor Type 1 (tumor type will be selected based on available data) will be randomized to receive XB371 at one of two recommended dose levels (recommended dose \\[RD\\]-1 or RD-2) every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.', 'interventionNames': ['Drug: XB371']}, {'type': 'EXPERIMENTAL', 'label': 'Dose-expansion Cohorts: Part B', 'description': 'Participants with Tumor Type 2 (tumor type will be selected based on available data) will receive XB371 at the recommended dose level every 3 weeks of a 21-day cycle (alternate schedules may be evaluated) until meeting the criteria for treatment discontinuation.', 'interventionNames': ['Drug: XB371']}], 'interventions': [{'name': 'XB371', 'type': 'DRUG', 'description': 'Intravenous (IV) infusion.', 'armGroupLabels': ['Dose-escalation Cohorts', 'Dose-expansion Cohorts: Part A', 'Dose-expansion Cohorts: Part B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72758', 'city': 'Rogers', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Exelixis Clinical Site #5', 'geoPoint': {'lat': 36.33202, 'lon': -94.11854}}, {'zip': '32827', 'city': 'Orlando', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Exelixis Clinical Site #4', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Exelixis Clinical Site #3', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Exelixis Clinical Site #2', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Exelixis Clinical Site #1', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'centralContacts': [{'name': 'Exelixis Clinical Trials', 'role': 'CONTACT', 'email': 'druginfo@exelixis.com', 'phone': '1-888-EXELIXIS (888-393-5494)'}, {'name': 'Backup or International', 'role': 'CONTACT', 'phone': '1-650-837-7400'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Exelixis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Exelixis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}