Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:15 AM
Study NCT ID:
NCT07357220
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-12', 'studyFirstSubmitDate': '2025-12-24', 'studyFirstSubmitQcDate': '2026-01-12', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants experiencing dose-limiting toxicities (DLTs)', 'timeFrame': 'From Day 1 to Day 28 after the first tumour vaccine was administrated in safety run-in cohorts', 'description': 'Number of participants who meet the criteria of dose-limiting toxicities (DLTs) in DLT observation period'}, {'measure': 'Number of participants with adverse events (AEs) and severity', 'timeFrame': 'From ICF up to 30 days after last study treatment', 'description': 'Number of participants experiencing adverse events (AEs) and severity, graded according to CTCAE v5.0'}, {'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Time Frame: Up to 2 years', 'description': 'Proportion of participants with complete response (CR) or partial response (PR), as assessed by RECIST version 1.1'}], 'secondaryOutcomes': [{'measure': 'Progression free survival (PFS)', 'timeFrame': 'Up to 2 years', 'description': 'Time from the date of enrollment until the first documentation of disease progression or death due to any cause, whichever occurs first, as assessed by RECIST version 1.1'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'Up to 2 years', 'description': 'Proportion of participants with complete response (CR), partial response (PR), or stable disease (SD), as assessed by RECIST version 1.1'}, {'measure': 'Duration of response (DoR)', 'timeFrame': 'Up to 2 years', 'description': 'Time from the first documentation of objective response to the first documented disease progression as assessed by RECIST version 1.1 or death due to any cause, whichever occurs first'}, {'measure': 'Time to response (TTR)', 'timeFrame': 'Up to 2 years', 'description': 'Time from the start of the treatment to the first objective tumor response observed for patients who achieved complete response (CR) or partial response (PR), as assessed by RECIST version 1.1'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'Up to 2 years', 'description': 'Time from the date of enrollment to death from any cause'}, {'measure': 'Observed concentrations of AK112', 'timeFrame': 'Up to 2 years', 'description': 'Observed serum concentrations of AK112 at different time points after AK112 administration'}, {'measure': 'Number of participants with detectable anti-drug antibodies (ADAs) to AK112', 'timeFrame': 'Up to 2 years', 'description': 'Number of participants who develop detectable anti-drug antibodies (ADAs) to AK112'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer With Hepatic Metastases']}, 'descriptionModule': {'briefSummary': 'An open-label, multicenter, phase Ib/II study of AK112 in combination with VG2025 for advanced colorectal cancer with liver metastases.', 'detailedDescription': 'This open-label, multicenter, phase Ib/II clinical study aims to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of AK112 in combination with VG2025, in the treatment of advanced colorectal cancer with liver metastases.'}, '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. Histologically or cytologically confirmed unresectable colorectal cancer with liver metastases; adenocarcinoma type\n4. Disease progression after first- or second-line standard therapy\n5. At least one measurable disease based on RECIST v1.1\n6. ECOG status of 0 or 1\n7. Estimated life expectancy≥3 months\n8. Adequate organ function\n9. Patients with fertility are willing to use an adequate method of contraception\n\nExclusion Criteria:\n\n1. Histologically or cytologically confirmed non-adenocarcinoma or mixed-type tumors with adenocarcinoma component ≤70%\n2. Known dMMR or MSI-H\n3. Known RAS or BRAF mutations\n4. Participation in another clinical trial\n5. Systemic anticancer therapy within 4 weeks, small molecule therapy within 2 weeks, antitumor traditional Chinese medicine within 2 weeks before first dose\n6. Prior immunotherapy other than anti-PD-(L)1 agents\n7. Live attenuated vaccine within 28 days before or during study treatment and 90 days after last dose\n8. Active malignancy within the past 3 years\n9. Known spinal cord compression, active brain or leptomeningeal metastases.\n10. Significant bleeding events requiring transfusion, invasive intervention, or hospitalization within 3 months before first dose\n11. Serious infection within 28 days, or systemic anti-infective therapy within 14 days before first dose (except antiviral therapy for hepatitis B/C)\n12. Active herpesvirus infection with clinical manifestations\n13. Active autoimmune disease\n14. Known immunodeficiency\n15. Known allergy to study drug or excipients, or history of severe allergic reactions to other vaccines\n16. History of allogeneic organ or hematopoietic stem cell transplantation.\n17. Clinically significant liver disease\n18. Any other situations that are not suitable for inclusion in this study judged by investigator'}, 'identificationModule': {'nctId': 'NCT07357220', 'briefTitle': 'A Study of AK112 in Combination With VG2025 in Colorectal Cancer With Liver Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akeso'}, 'officialTitle': 'A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of AK112 in Combination With VG2025 in Patients With Advanced Colorectal Cancer With Liver Metastases', 'orgStudyIdInfo': {'id': 'AK112-212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A (VG2025+AK112)', 'description': 'VG2025 (Recommended Phase II Dose), Intratumoral Injection, Q4W + AK112 (20mg/kg), ivgtt, Q2W.', 'interventionNames': ['Biological: VG2025', 'Drug: AK112']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B (AK112)', 'description': 'AK112 (20mg/kg), ivgtt, Q2W', 'interventionNames': ['Drug: AK112']}], 'interventions': [{'name': 'VG2025', 'type': 'BIOLOGICAL', 'description': 'Recommended Phase II Dose, Intratumoral Injection, Q4W', 'armGroupLabels': ['Cohort A (VG2025+AK112)']}, {'name': 'AK112', 'type': 'DRUG', 'description': '20mg/kg, ivgtt, Q2W', 'armGroupLabels': ['Cohort A (VG2025+AK112)', 'Cohort B (AK112)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Liang Tingbo, MD', 'role': 'CONTACT', 'email': 'liangtingbo@zju.edu.cn', 'phone': '+86-13486180288'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine，No. 79, Qingchun Road, Shangcheng District, Hangzhou City, Zhejiang Province', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ting Liu', 'role': 'CONTACT', 'email': 'clinicaltrials@akesobio.com', 'phone': '+86 (0760) 8987 3999'}, {'name': 'Tingbo Liang, MD', 'role': 'CONTACT', 'email': 'liangtingbo@zju.edu.cn', 'phone': '+86-13486180288'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akeso', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shanghai Virogin Biotech Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}