Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 8:00 AM
Study NCT ID:
NCT06022250
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-09-18
First Post:
2023-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
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': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-17', 'studyFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2023-08-28', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-limiting toxicity （DLT）、adverse event（AE）', 'timeFrame': '2 Years', 'description': 'Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance'}, {'measure': 'Maximum tolerated dose (MTD),RP2D', 'timeFrame': '2 Years', 'description': 'Maximum tolerated dose (MTD), Recommended dose for phase II trial'}], 'secondaryOutcomes': [{'measure': 'Peak concentration（Cmax）', 'timeFrame': '2 years', 'description': 'The highest plasma drug concentration that can be achieved after medication'}, {'measure': 'Time to peak（Tmax）', 'timeFrame': '2 years', 'description': 'After a single dose, the time of peak blood concentration'}, {'measure': 'Elimination half life（t1/2）', 'timeFrame': '2 years', 'description': 'The time it takes the blood to reduce the concentration of the drug to half'}, {'measure': 'Progression free survival(PFS)', 'timeFrame': '2 years', 'description': 'The time from first dose to Disease progression or death'}, {'measure': 'Overall survival (OS)', 'timeFrame': '2 years', 'description': 'The time from first dose to death from any cause'}, {'measure': 'Immunogenicity', 'timeFrame': '2 years', 'description': 'Incidence of Anti-Drug Antibody (ADA)'}, {'measure': 'Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)', 'timeFrame': '2 years', 'description': 'Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Malignant Tumor']}, 'descriptionModule': {'briefSummary': 'This is a Phase I open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK),Pharmacodynamic characteristics, immunogenicity and antitumor activity of JS207 in patients with advanced malignant tumor. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable;\n2. Eastern Cooperative Oncology Group (ECOG) 0 or 1;\n3. Life expectancy ≥ 12 weeks;\n4. At least one measurable lesion according to RECIST 1.1;\n5. Adequate organ function;\n\nExclusion Criteria:\n\n1. central nervous system metastasis；\n2. There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)；\n3. Images in screening showed that the tumor surrounded important blood vessels or had obvious necrosis and voids, and the investigators believed that it might cause bleeding risk；\n4. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures；\n5. A history of significant bleeding tendency or severe coagulopathy；\n6. The presence of poorly controlled hypertension；'}, 'identificationModule': {'nctId': 'NCT06022250', 'briefTitle': 'The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Junshi Bioscience Co., Ltd.'}, 'officialTitle': 'A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor', 'orgStudyIdInfo': {'id': 'JS207-001-I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'JS207', 'interventionNames': ['Drug: JS207']}], 'interventions': [{'name': 'JS207', 'type': 'DRUG', 'description': 'Patients will receive specific dose of JS207 via intravenous infusion.', 'armGroupLabels': ['JS207']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250117', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Affiliated Cancer Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Junshi Bioscience Co., Ltd.', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sponsor GmbH', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}