Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2026-01-02 @ 2:43 AM
Study NCT ID:
NCT06951503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-30
First Post:
2025-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase III, Randomized, Controlled and Multi-center Study of AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000077146', 'term': 'Irinotecan'}, {'id': 'D002955', 'term': 'Leucovorin'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002166', 'term': 'Camptothecin'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005575', 'term': 'Formyltetrahydrofolates'}, {'id': 'D013763', 'term': 'Tetrahydrofolates'}, {'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 560}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-01-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2025-04-23', 'studyFirstSubmitQcDate': '2025-04-23', 'lastUpdatePostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival (PFS) assessed by blinded independent central review (BICR)', 'timeFrame': 'Up to approximately 3 years', 'description': 'PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).'}], 'secondaryOutcomes': [{'measure': 'Overall survival (OS)', 'timeFrame': 'Up to approximately 5 years', 'description': 'OS is defined as the time from randomization to death due to any cause.'}, {'measure': 'Progression-free survival (PFS) assessed by investigator', 'timeFrame': 'Up to approximately 3 years', 'description': 'PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first (based on RECIST 1.1 criteria).'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to approximately 3 years', 'description': 'ORR is defined as proportion of subjects who have a complete or partial response relative to baseline according to RECIST 1.1 criteria.'}, {'measure': 'Duration of Response (DoR)', 'timeFrame': 'Up to approximately 3 years', 'description': 'DoR is defined as the duration from the first documentation of objective response to the first documented disease progression(based on RECIST v1.1 criteria) or death due to any cause, whichever occurs first.'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to approximately 3 years', 'description': 'DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST v1.1 criteria).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'This trial is a Phase III study. The purpose of this study is to evaluate the efficacy and safety of AK112 and chemotherapy versus bevacizumab and chemotherapy for the first-line treatment of metastatic colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed informed consent.\n2. Age ≥ 18 years and ≤ 75 years.\n3. ECOG status of 0 or 1.\n4. Estimated survival ≥ 3 months.\n5. Subjects with histologically or cytologically confirmed metastatic colorectal adenocarcinoma.\n6. Subjects who are not candidates for radical surgical resection or local therapy and have not received systemic anti-tumor therapy in the recurrent or metastatic setting. Subjects who have received prior neoadjuvant or adjuvant therapy and whose first discovery of recurrence or metastases is ≥ 12 months after the last dose of neoadjuvant or adjuvant therapy are allowed to enroll.\n7. At least one measurable disease based on RECIST v1.1.\n8. Adequate organ function per protocol-defined criteria.\n9. Women of childbearing potential and men with female partners of childbearing potential must agree to use effective contraception during treatment and for at least 180 days following the last dose of study treatment.\n\nExclusion Criteria:\n\n1. Previous (within 3 years) or concurrent other malignant tumors, excluding those that have been cured.\n2. Participating in other interventional study within 4 weeks prior to the first study drug administration.\n3. Palliative local treatment for non-target lesions within 2 weeks prior to the first administration; received non-specific immunomodulatory therapy within 2 weeks prior to the first administration.\n4. Current presence of uncontrolled combined disease.\n5. Active clinical infections.\n6. History of severe bleeding tendency or coagulation dysfunction.\n7. Subjects with known active tuberculosis (TB); suspected active TB should be excluded by clinical examination, known active syphilis infection.\n8. Received a live vaccine within 30 days prior to the study, or plan to receive a live vaccine during the study.\n9. Current presence of significant radiographic or clinical manifestations of GI obstruction.\n10. Toxicities of prior anticancer therapy have not resolved to ≤ Grade 1 (NCI-CTCAE version 5.0).\n11. Pregnant or lactating women.\n12. Any condition considered by the investigator to be inappropriate for enrollment.\n13. Local or systemic disease caused by non-malignancy, or disease or symptom secondary to tumor, that can lead to higher medical risk and/or uncertainty in survival.'}, 'identificationModule': {'nctId': 'NCT06951503', 'briefTitle': 'A Phase III, Randomized, Controlled and Multi-center Study of AK112 and Chemotherapy in First-line Metastatic Colorectal Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akeso'}, 'officialTitle': 'A Randomized, Controlled, Multicenter Phase III Clinical Study of AK112 Combined With Chemotherapy Versus Bevacizumab Combined With Chemotherapy in First-line Metastatic Colorectal Cancer', 'orgStudyIdInfo': {'id': 'AK112-312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AK112 in combination with FOLFOXIRI', 'description': 'AK112 in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus AK112.', 'interventionNames': ['Drug: AK112', 'Drug: Oxaliplatin', 'Drug: Irinotecan', 'Drug: Leucovorin and 5-FU']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bevacizumab in combination with FOLFOXIRI', 'description': 'Bevacizumab in combination with FOLFOXIRI (Irinotecan, Oxaliplatin, Leucovorin and 5-FU) for induction treatment. Later, patients will receive maintenance Leucovorin and 5-FU plus Bevacizumab .', 'interventionNames': ['Drug: Oxaliplatin', 'Drug: Irinotecan', 'Drug: Leucovorin and 5-FU', 'Drug: Bevacizumab']}], 'interventions': [{'name': 'AK112', 'type': 'DRUG', 'description': 'iv, q2w', 'armGroupLabels': ['AK112 in combination with FOLFOXIRI']}, {'name': 'Oxaliplatin', 'type': 'DRUG', 'description': 'iv, q2w', 'armGroupLabels': ['AK112 in combination with FOLFOXIRI', 'Bevacizumab in combination with FOLFOXIRI']}, {'name': 'Irinotecan', 'type': 'DRUG', 'description': 'iv, q2w', 'armGroupLabels': ['AK112 in combination with FOLFOXIRI', 'Bevacizumab in combination with FOLFOXIRI']}, {'name': 'Leucovorin and 5-FU', 'type': 'DRUG', 'description': 'iv, q2w', 'armGroupLabels': ['AK112 in combination with FOLFOXIRI', 'Bevacizumab in combination with FOLFOXIRI']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'description': 'iv, q2w', 'armGroupLabels': ['Bevacizumab in combination with FOLFOXIRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guanzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Yanhong DENG, MD', 'role': 'CONTACT'}], 'facility': 'The Sixth Hospital,Sun Yat-sen University', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}, {'city': 'Guanzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Ruihua Xu, MD', 'role': 'CONTACT'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.06828, 'lon': 113.37117}}], 'centralContacts': [{'name': 'Xufang Yu, MD', 'role': 'CONTACT', 'email': 'clincialtrails@akesobio.com', 'phone': '+86(0760)89873999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akeso', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}