Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:55 AM
Study NCT ID:
NCT07322094
Status:
RECRUITING
Last Update Posted:
2026-01-07
First Post:
2025-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005185', 'term': 'Fallopian Tube Neoplasms'}], 'ancestors': [{'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005184', 'term': 'Fallopian Tube Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D056831', 'term': 'Coordination Complexes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-05', 'studyFirstSubmitDate': '2025-12-17', 'studyFirstSubmitQcDate': '2026-01-05', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterize the safety and feasibility of TORL-1-23 in combination with chemotherapy by analyzing the incidence of treatment emergent adverse events and serious adverse events.', 'timeFrame': 'Treatment during Cycle 1 to Cycle 4 (Each cycle is 21 days)', 'description': 'Incidence of Grade greater than or equal to 3 (using CTCAE V5.0) treatment-emergent adverse event (TEAE) and related serious adverse event (SAE)'}, {'measure': 'To assess the efficacy of neoadjuvant TORL-1-23 in combination with chemotherapy', 'timeFrame': 'postoperative after Cycle 4 (Each cycle is 21 days)', 'description': 'Determination of percentage CRS3 score for each treatment arm'}], 'secondaryOutcomes': [{'measure': 'To assess the tolerability of TORL-1-23 in combination with chemotherapy', 'timeFrame': 'Treatment up to Cycle 8 (each cycle is 21 days)', 'description': 'Safety assessed by incidence of intolerable Grade 2 and Grade greater than or equal to 3 TEAE and related SAE.'}, {'measure': 'To characterize duration of benefit for TORL-1-23 plus chemotherapy', 'timeFrame': 'Measured up to 15 months after surgery', 'description': 'Relapse free survival for participants'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['FIGO Stage III and IV Ovarian Cancer', 'Fallopian Tube Cancers', 'Primary Peritoneal Cancer']}, 'descriptionModule': {'briefSummary': 'A Phase 1B/2 Study to Investigate the Safety and Efficacy of TORL-1-23 with Chemotherapy Given Before Initial Surgery in Women with Advanced Stage Ovarian Cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.\n* Histologically or cytologically confirmed diagnosis of epithelial ovarian, primary peritoneal or fallopian tubes cancer\n* FIGO Stage III or IV\n* Positive for claudin 6 (CLDN6) expression\n* Adequate organ function\n\nExclusion Criteria:\n\n* Clear cell, mucinous, sarcomatous, mixed histology, low-grade/borderline, or non-epithelial ovarian cancers\n* Prior systemic treatment for the disease under study\n* Prior surgery\n* Prior radiation therapy to the abdomen or pelvis\n* Current recipient or receipt within 5-half-lives of C1D1 of chemotherapy, biologic/targeted therapy, immunomodulator therapy for any disease indication\n* Active, progressive, or symptomatic brain metastases\n* Participants considered poor medical risks due to serious, uncontrolled medical conditions, active infections, or nonmalignant systemic diseases\n* Pregnant or breastfeeding women'}, 'identificationModule': {'nctId': 'NCT07322094', 'briefTitle': 'CATALINA-4: A Study to Investigate the Safety and Efficacy of TORL-1-23 With Chemotherapy Given Before Initial Surgery in Women With Advanced Stage Ovarian Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'TORL Biotherapeutics, LLC'}, 'officialTitle': 'CATALINA-4: Phase 1B/2 Study of TORL-1-23 With Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Newly Diagnosed Patients With Advanced Stage Ovarian Cancer', 'orgStudyIdInfo': {'id': 'TORL123-004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm A: TORL-1-23 and paclitaxel', 'description': 'Administered once every three weeks', 'interventionNames': ['Combination Product: TORL-1-23 and paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm B: TORL-1-23 and carboplatin', 'description': 'Administered once every three weeks', 'interventionNames': ['Combination Product: TORL-1-23 and carboplatin']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin', 'description': 'Administered once every three weeks', 'interventionNames': ['Combination Product: TORL-1-23, paclitaxel, and carboplatin']}], 'interventions': [{'name': 'TORL-1-23 and paclitaxel', 'type': 'COMBINATION_PRODUCT', 'description': 'TORL-1-23 and paclitaxel', 'armGroupLabels': ['Treatment Arm A: TORL-1-23 and paclitaxel']}, {'name': 'TORL-1-23 and carboplatin', 'type': 'COMBINATION_PRODUCT', 'description': 'TORL-1-23 and carboplatin', 'armGroupLabels': ['Treatment Arm B: TORL-1-23 and carboplatin']}, {'name': 'TORL-1-23, paclitaxel, and carboplatin', 'type': 'COMBINATION_PRODUCT', 'description': 'TORL-1-23, paclitaxel, and carboplatin', 'armGroupLabels': ['Treatment Arm C: TORL-1-23, paclitaxel, and carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'phone': '310-348-9636'}], 'facility': 'UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'centralContacts': [{'name': 'Caroline Labib, PharmD', 'role': 'CONTACT', 'email': 'caroline.labib@torlbio.com', 'phone': '310-348-9636'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TORL Biotherapeutics, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}