Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-01-06 @ 7:20 AM
Study NCT ID:
NCT05194995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2021-12-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001063', 'term': 'Appendiceal Neoplasms'}], 'ancestors': [{'id': 'D002430', 'term': 'Cecal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068818', 'term': 'Cetuximab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2021-12-27', 'studyFirstSubmitQcDate': '2022-01-04', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Escalation phase: Number of participants with dose-limiting toxicities (DLTs)', 'timeFrame': 'At the end of Cycle 1 (each cycle is 21 days)', 'description': 'A DLT is defined as the clinically significant treatment related adverse event (TRAE) or abnormal laboratory values assessment during the first 21 days of (Cycle 1) and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.'}, {'measure': 'Dose Expansion phase: Overall response rate (ORR)', 'timeFrame': 'Up to 4 years - from baseline to RECIST confirmed Progressive Disease', 'description': 'ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.'}], 'secondaryOutcomes': [{'measure': 'Dose Escalation and Dose Expansion phase: Number of participants with adverse events', 'timeFrame': 'Up to 4 years', 'description': 'Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE criteria.'}, {'measure': 'Dose Escalation and Dose Expansion phase: Peak Plasma Concentration (Cmax)', 'timeFrame': 'Up to 4 years', 'description': 'Cmax of JAB-21822 will be measured by using plasma PK samples.'}, {'measure': 'Dose Escalation and Dose Expansion phase: Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Up to 4 years', 'description': 'AUC of JAB-21822 will be measured by using plasma PK samples.'}, {'measure': 'Dose Expansion phase: Duration of response ( DOR )', 'timeFrame': 'Up to 4 years', 'description': "DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first."}, {'measure': 'Dose Escalation phase: Overall response rate (ORR)', 'timeFrame': 'Up to 4 years', 'description': 'The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.'}, {'measure': 'Dose Expansion phase: Disease Control Rate ( DCR )', 'timeFrame': 'Up to 4 years', 'description': 'DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease(SD) per CTCAE v1.1.'}, {'measure': 'Dose Expansion phase: Progression-free survival (PFS)', 'timeFrame': 'Up to 4 years', 'description': 'PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Colorectal Cancer', 'Small Intestinal Cancer', 'Appendiceal Cancer']}, 'referencesModule': {'references': [{'pmid': '41344351', 'type': 'DERIVED', 'citation': 'Li J, Wang Z, Huang J, Ba Y, Cao B, Luo S, Li W, Bai C, Song Z, Xiong J, Zhu L, An G, Zhang Y, Li Z, Li Y, Gu Y, Hu C, Li X, Huang C, Fu Q, Yin X, Liang X, Zhong D, Shi H, Li X, Li Z, Liu L, Wang F, Liang R, Xia G, Wang Z, Wang-Gillam A, Ding Y, Rao Z, Pan W, Lu S, Sun X, Shen L. Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials. Lancet Gastroenterol Hepatol. 2025 Dec 1:S2468-1253(25)00267-5. doi: 10.1016/S2468-1253(25)00267-5. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'This study is to evaluate the safety, tolerability, pharmacokinetics and antitumor activity of JAB-21822 in combination with cetuximab in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.', 'detailedDescription': 'The primary objective of this study is to evaluate the safety and tolerability of JAB-21822 in combination with cetuximab to determine the MTD and RP2D during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-21822 is administered in combination with cetuximab during Dose Expansion phase in patients with advanced colorectal cancer，advanced small intestine cancer and advanced appendiceal cancer with KRAS p.G12C mutation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants must be able to provide an archived tumor sample\n* Histologically or cytologically confirmed advanced colorectal cancer, advanced small intestinal cancer and advanced appendiceal cancer with KRAS p.G12C mutation\n* Must have received at least 1 prior standard therapy\n* Must have at least 1 measurable lesion per RECIST v1.1\n* Must have adequate organ function\n* Must be able to swallow and retain orally administered medication\n\nExclusion Criteria:\n\n* Has brain metastases, except if treated and no evidence of radiographic progression or hemorrhage for at least 28 days\n* Active infection requiring systemic treatment within 14 days\n* Active HIV, HBV or HCV\n* Any severe and/or uncontrolled medical conditions\n* LVEF\\<50% assessed by ECHO\n* QT interval \\>470 msec'}, 'identificationModule': {'nctId': 'NCT05194995', 'briefTitle': 'JAB-21822 in Combination With Cetuximab in Patients With Advanced CRC and Other Solid Tumors With KRAS G12C Mutation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allist Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase Ib/II Trial of JAB-21822 in Combination With Cetuximab in Patients With Advanced Colorectal Cancer, Small Intestine Cancer and Appendiceal Cancer With KRAS G12C Mutation', 'orgStudyIdInfo': {'id': 'JAB-21822-1007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1b Dose Escalation', 'description': 'Dose escalation of JAB-21822 to determine maximum tolerated dose of JAB-21822 in combination with cetuximab.', 'interventionNames': ['Drug: JAB-21822', 'Drug: Cetuximab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Dose Expansion, Cohort 1', 'description': 'Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced colorectal cancer.', 'interventionNames': ['Drug: JAB-21822', 'Drug: Cetuximab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2 Dose Expansion, Cohort 2', 'description': 'Enrollment into the dose expansion cohort is for eligible participants with KRAS P.G12C mutant advanced small intestinal cancer and advanced appendiceal cancer.', 'interventionNames': ['Drug: JAB-21822', 'Drug: Cetuximab']}], 'interventions': [{'name': 'JAB-21822', 'type': 'DRUG', 'description': 'JAB-21822 administered orally as a tablet.', 'armGroupLabels': ['Phase 1b Dose Escalation', 'Phase 2 Dose Expansion, Cohort 1', 'Phase 2 Dose Expansion, Cohort 2']}, {'name': 'Cetuximab', 'type': 'DRUG', 'description': 'Cetuximab administered as an intravenous (IV) infusion.', 'armGroupLabels': ['Phase 1b Dose Escalation', 'Phase 2 Dose Expansion, Cohort 1', 'Phase 2 Dose Expansion, Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100021', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research site31', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100101', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research site01', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100101', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research site02', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100101', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research site12', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'country': 'China', 'facility': 'Research site13', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '150000', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Research site06', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Research site05', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'country': 'China', 'facility': 'Research site07', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '430079', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Research site18', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Research site11', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '410000', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'Research site29', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'zip': '210000', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research site09', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '330000', 'city': 'Nanchang', 'state': 'Jiangxi', 'country': 'China', 'facility': 'Research site08', 'geoPoint': {'lat': 28.68396, 'lon': 115.85306}}, {'zip': '276002', 'city': 'Linyi', 'state': 'Shandong', 'country': 'China', 'facility': 'Research site16', 'geoPoint': {'lat': 35.06306, 'lon': 118.34278}}, {'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Research site28', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710000', 'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research site23', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'zip': '310005', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research site19', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Shen Lin Master of medicine', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Cancer Hospital & Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allist Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}