Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT06913218
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-06
First Post:
2025-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-22', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-11-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-30', 'studyFirstSubmitDate': '2025-03-30', 'studyFirstSubmitQcDate': '2025-03-30', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': 'Day 1 to Day 21 after the first tumour vaccine was administrated', 'description': 'Percentage of subjects who meet the criteria of DLT in DLT observation period'}, {'measure': 'AE', 'timeFrame': 'From ICF up to 30days after last study treatment', 'description': 'Percentage of subjects with Adverse Events (AEs)'}], 'secondaryOutcomes': [{'measure': 'RFS', 'timeFrame': '2 years', 'description': 'Recurrence free survival（RFS）'}, {'measure': 'OS', 'timeFrame': '2 years', 'description': 'Overall survival（OS）'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adjuvant', 'pancreas cancer', 'mRNA'], 'conditions': ['Pancreas Cancer', 'Pancreas Cancer, Duct Cell Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'To explore safety and efficacy of neoantigen personalized mRNA vaccines AK154 monotherapy or in combination with AK104/AK112 and sequential mFOLFIRINOX regime in Resected PDAC', 'detailedDescription': 'This is a prospective, open-label, single-center, exploratory clinical study. To explore the safety, tolerability, efficacy, immunogenicity, and PK/PD profile of neoantigen personalized mRNA vaccine AK154 monotherapy or combined with AK104 or AK112, sequential mFOLFIRINOX chemotherapy regimen as postoperative adjuvant therapy in Surgically Resected Pancreatic Adenocarcino'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntarily signed the informed consent form and complied with protocols requirements\n* Patients with radiographically resectable primary pancreatic tumors\n* Histopathology or cytology confirmed resected PDAC with macroscopic complete resection (R0 and R1)\n* Pancreatic cancer surgical staging per AJCC 8th edition staging: T 1-3, N0-2, M0\n* ECOG 0 or 1\n* Life expectancy ≥ 6 months\n* Surgical complications have recovered,\n* Adequate organ function\n* Patients with fertility are willing to use an adequate method of contraception.\n\nExclusion Criteria:\n\n* The presence of other pathologic types\n* Participating in another clinical study\n* Have received treatment for pancreatic cancer, including chemotherapy, radiation therapy, targeted therapy, immunotherapy,etc\n* Plan to receive a live-attenuated vaccine within 28 days prior to initiation of study treatment or during the study treatment or within 90 days after the end of study treatment\n* Severe infection occurs within 4 weeks prior to the first dose\n* Requiring systemic therapy with glucocorticoids or other immunosuppressive drugs within 14 days prior to initial administration.\n* Acute pancreatitis or subclinical pancreatitis\n* Active autoimmune disease\n* Allergic to immunotherapies and related drugs\n* History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n* Splenectomy history\n* Active tuberculosis\n* Known or highly suspected history of interstitial pneumonia.\n* Clinically significant liver disease\n* Uncontrolled or severe cardiovascular disease.\n* Severe bleeding tendency or history of coagulopathy\n* Active malignancy within the last 3 years\n* Active syphilis infection\n* Any other situations that are not suitable for inclusion in this study judged by investigator.'}, 'identificationModule': {'nctId': 'NCT06913218', 'briefTitle': 'A Study of mRNA Vaccines AK154 Monotherapy or in Combination With AK104/AK112,and Sequential mFOLFIRINOX in Surgically Resected PDAC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akeso'}, 'officialTitle': 'An Exploratory Study to Evaluate Safety and Efficacy of the Neoantigen Personalized mRNA Vaccine AK154 Monotherapy or in Combination With AK104 or AK112,and the Sequential mFOLFIRINOX Regimen as Adjuvant Therapy in Surgically Resectable Pancreatic Ductal Adenocarcinoma', 'orgStudyIdInfo': {'id': 'AK154-IIT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pancreatic Cancer', 'description': 'Resectable PDAC', 'interventionNames': ['Biological: AK154', 'Biological: Cadonilimab', 'Biological: Ivonescimab (SMT112 or AK112) Injection', 'Drug: mFOLFORINOX']}], 'interventions': [{'name': 'AK154', 'type': 'BIOLOGICAL', 'description': 'AK154 is neotigeon personalized mRNA vaccine', 'armGroupLabels': ['Pancreatic Cancer']}, {'name': 'Cadonilimab', 'type': 'BIOLOGICAL', 'description': 'a PD-1/CTLA-4 bispecific antibody', 'armGroupLabels': ['Pancreatic Cancer']}, {'name': 'Ivonescimab (SMT112 or AK112) Injection', 'type': 'BIOLOGICAL', 'description': 'a PD-1/VEGF bi-specific antibody', 'armGroupLabels': ['Pancreatic Cancer']}, {'name': 'mFOLFORINOX', 'type': 'DRUG', 'description': 'mFOLFIRINOX:Fluorouracil+leucovorin+Irinotecan+Oxaliplatin', 'armGroupLabels': ['Pancreatic Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Xuhui', 'country': 'China', 'contacts': [{'name': 'Xianjun Yu, PhD,MD', 'role': 'CONTACT', 'email': 'fuscc_gjswb@163.com', 'phone': '021-33988888'}], 'facility': 'Department of Pancreatic Surgery,Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Ting Liu', 'role': 'CONTACT', 'email': 'clinicaltrials@akesobio.com', 'phone': '+86 (0760) 8987 3999'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akeso', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fudan University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}