Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:30 PM
Study NCT ID:
NCT06195293
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2023-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2037-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-22', 'studyFirstSubmitDate': '2023-12-22', 'studyFirstSubmitQcDate': '2023-12-22', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients with Dose Limiting Toxicity', 'timeFrame': 'Six months', 'description': 'A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.'}], 'secondaryOutcomes': [{'measure': 'Percent of Patients with best response as either complete remission or partial remission.', 'timeFrame': 'Six months', 'description': 'Response rates will be estimated as the percent of patients whose best response is either complete remission or partial remission by combining the data from the patients. To compare with historical data, a 95% confidence interval will be calculated for the response rate.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Solid Tumor', 'Polypeptide Vaccine', 'Immunotherapy'], 'conditions': ['Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': 'The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.', 'detailedDescription': '1. Choose appropriate patients with advanced solid cancers, with written consent for this study;\n2. Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;\n3. Produce appropriate polypeptide vaccine for human use and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;\n4. To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;\n5. Evaluate the clinical results as needed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients with advanced cancer; 2. Life expectancy \\>12 weeks; 3. Adequate heart, lung, liver, kidney, and blood function; 4. Available high quality vaccine for human use; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.\n\n\\-\n\nExclusion Criteria:\n\n1. Had accepted gene therapy before;\n2. Severe virus infection such as HBV, HCV, HIV, et al;\n3. Known HIV positivity;\n4. Active infectious disease related to bacteria, virus,fungi,et al;\n5. Other severe diseases that the investigators consider not appropriate;\n6. Pregnant or lactating women;\n7. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);\n8. Other conditions that the investigators consider not appropriate.'}, 'identificationModule': {'nctId': 'NCT06195293', 'briefTitle': 'Anti-cancer Neoantigen Polypeptide Vaccine to Treat Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital of Guangzhou Medical University'}, 'officialTitle': 'Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial', 'orgStudyIdInfo': {'id': 'ZZVACCINE-POLYPEPTIDE-021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-cancer Neoantigen Polypeptide Vaccine', 'description': 'Anti-cancer neoantigen polypeptide vaccine will be produced to treat advanced solid tumors.', 'interventionNames': ['Biological: Neoantigen Polypeptide Vaccine']}], 'interventions': [{'name': 'Neoantigen Polypeptide Vaccine', 'type': 'BIOLOGICAL', 'description': 'Deliver neoantigen polypeptide vaccine into patients for anti-ancer therapy.', 'armGroupLabels': ['Anti-cancer Neoantigen Polypeptide Vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510260', 'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenfeng Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zhangzhf@gzhmu.edu.cn', 'phone': '+862039195966'}, {'name': 'Bingjia He', 'role': 'CONTACT', 'email': '464677938@qq.com', 'phone': '+862039195965'}, {'name': 'Zhenfeng Zhang, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Second Affiliated Hospital of Guangzhou Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhenfeng Zhang, MD, PhD', 'role': 'CONTACT', 'email': 'zhangzhf@gzhmu.edu.cn', 'phone': '0086-020-39195965'}, {'name': 'Bingjia He, MD', 'role': 'CONTACT', 'email': '464677938@qq.com', 'phone': '+862039195965'}], 'overallOfficials': [{'name': 'Zhenfeng Zhang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital of Guangzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}