Status:
ACTIVE_NOT_RECRUITING
The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Collaborating Sponsors:
Sponsor GmbH
Conditions:
Advanced Malignant Tumor
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable;
- Eastern Cooperative Oncology Group (ECOG) 0 or 1;
- Life expectancy ≥ 12 weeks;
- At least one measurable lesion according to RECIST 1.1;
- Adequate organ function;
Exclusion
- central nervous system metastasis；
- There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)；
- 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；
- The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures；
- A history of significant bleeding tendency or severe coagulopathy；
- The presence of poorly controlled hypertension；
Key Trial Info
Start Date :
September 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT06022250
Start Date
September 26 2023
End Date
June 30 2026
Last Update
September 18 2025
Active Locations (1)
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1
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117