Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-26 @ 1:30 AM
Study NCT ID:
NCT04492033
Status:
TERMINATED
Last Update Posted:
2025-01-27
First Post:
2020-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621806', 'term': 'asciminib'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000077146', 'term': 'Irinotecan'}], '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': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'whyStopped': 'Change of Development Plan', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-23', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-07-29', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)', 'timeFrame': 'From Day 1 until disease progression or Day 28, whichever came first', 'description': 'Number of subjects who experience DLT events during 28 days after first administration of CTX-009 (ABL001) and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects'}, {'measure': 'P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC', 'timeFrame': 'Up to approximately 24 months', 'description': "The proportion of subjects whose best overall response (BOR) is assessed to be complete response (CR) or partial response (PR) as per Independent Radiology Center's review"}], 'secondaryOutcomes': [{'measure': 'Adverse Events (AEs)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0'}, {'measure': 'Pharmacokinetics (PK) of CTX-009 (ABL001)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001)'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to approximately 24 months', 'description': "Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review"}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)'}, {'measure': 'Time to treatment failure (TTF)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Time interval from 1st administration of CTX-009 (ABL001) to the time of disease progression or discontinuation of CTX-009 (ABL001) due to whatever reason, whichever comes first'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Time interval from first occurrence of a documented objective response to the time of disease progression'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'Up to approximately 24 months', 'description': 'The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death'}, {'measure': 'P2: Survival rate', 'timeFrame': '6 months and 12 months', 'description': 'The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment'}, {'measure': 'P2: Overall survival (OS)', 'timeFrame': 'Up to approximately 24 months', 'description': 'Time from the initiation of treatment to death'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VEGF', 'DLL4', 'Solid Tumors', 'Bispecific antibody', 'anti-angiogenic'], 'conditions': ['P1b: Advanced Solid Tumors', 'P2: Biliary Tract Cancer']}, 'descriptionModule': {'briefSummary': 'This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients with advanced or metastatic solid tumors.', 'detailedDescription': 'Phase 1b Study:\n\nIndication of phase 1b study is the advanced or metastatic solid tumors (including, but not limited to, colorectal cancer, gastric cancer, and ovarian cancer).\n\nPhase 2 Study:\n\nIndication of phase 2 study is unresectable advanced, metastatic or recurrent biliary tract cancer (BTC) (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* P1b only: Patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors\n* P2 only: Patients with histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, ampullary carcinoma)\n* P2 only: Patients who have shown disease progress or recurrence of disease after receiving first-line or second-line systemic chemotherapy, including treatment with gemcitabine in combination with a platinum agent\n* Patients aged 19 years or older\n* At least one lesion measurable defined by response evaluation criteria in solid tumors (RECIST) version 1.1.\n* Life expectancy ≥ 12 weeks\n* ECOG performance status 0 or 1\n* Women of childbearing potential must have a negative pregnancy test outcome\n* Patients must provide written informed consent to voluntary participation in this study\n\nKey Exclusion Criteria:\n\n* History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody) and irinotecan or paclitaxel\n* Less than 4 weeks have elapsed since a surgery\n* History of cardiac illness: New York Heart Association (NYHA) class ≥ II congestive heart failure (CHF), uncontrolled hypertension, hypertension crisis, pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina\n* Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the previous anticancer therapy\n* Severe infections or major and unhealed injury (active ulcer, untreated fracture)\n* Symptomatic or uncontrolled central nervous system (CNS) metastasis\n* Pregnant or lactating women or patients planning to become pregnant during the study\n* Participation in another clinical trial within 30 days prior to initiation of study treatment and received an investigational drug treatment\n* Administration of antiplatelets or anticoagulants within 2 weeks prior to screening\n* Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids\n* HIV or other severe diseases that warrant the exclusion from this study'}, 'identificationModule': {'nctId': 'NCT04492033', 'briefTitle': 'A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Handok Inc.'}, 'officialTitle': 'A Phase 1b/2a Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors', 'orgStudyIdInfo': {'id': 'ABL001-P1bC'}, 'secondaryIdInfos': [{'id': 'CTX-009-001', 'type': 'OTHER', 'domain': 'Compass Therapeutics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTX-009 (ABL001) and Paclitaxel (P1b)', 'interventionNames': ['Drug: CTX-009 (ABL001)', 'Drug: Paclitaxel']}, {'type': 'EXPERIMENTAL', 'label': 'CTX-009 (ABL001) and Irinotecan (P1b)', 'description': '1 cycle = 4weeks', 'interventionNames': ['Drug: CTX-009 (ABL001)', 'Drug: Irinotecan']}, {'type': 'EXPERIMENTAL', 'label': 'CTX-009 (ABL001) and Paclitaxel (P2)', 'description': '1 cycle = 4weeks', 'interventionNames': ['Drug: CTX-009 (ABL001)', 'Drug: Paclitaxel']}], 'interventions': [{'name': 'CTX-009 (ABL001)', 'type': 'DRUG', 'description': 'CTX-009 (ABL001) will be administered biweekly.', 'armGroupLabels': ['CTX-009 (ABL001) and Irinotecan (P1b)', 'CTX-009 (ABL001) and Paclitaxel (P1b)', 'CTX-009 (ABL001) and Paclitaxel (P2)']}, {'name': 'Paclitaxel', 'type': 'DRUG', 'description': 'Paclitaxel will be administered weekly.', 'armGroupLabels': ['CTX-009 (ABL001) and Paclitaxel (P1b)', 'CTX-009 (ABL001) and Paclitaxel (P2)']}, {'name': 'Irinotecan', 'type': 'DRUG', 'description': 'Irinotecan will be administered biweekly.', 'armGroupLabels': ['CTX-009 (ABL001) and Irinotecan (P1b)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam-si', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Handok Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Compass Therapeutics', 'class': 'INDUSTRY'}, {'name': 'ABL Bio, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}