NCT06022250Active, not recruitingPhase 1
A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
Shanghai Junshi Bioscience Co., Ltd.1 site in 1 country98 target enrollmentStarted: September 26, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 98
- Locations
- 1
- Primary Endpoint
- Dose-limiting toxicity （DLT）、adverse event（AE）
Study Overview
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 with advanced malignant tumor. The Recommended dose for phase II trial （RP2D） will be determined based on the safety, tolerability, pharmacokinetics.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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；
Arms & Interventions
JS207
Experimental
Intervention: JS207 (Drug)
Outcomes
Primary Outcomes
Dose-limiting toxicity （DLT）、adverse event（AE）
Time Frame: 2 Years
Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance
Maximum tolerated dose (MTD),RP2D
Time Frame: 2 Years
Maximum tolerated dose (MTD), Recommended dose for phase II trial
Secondary Outcomes
- Elimination half life（t1/2）(2 years)
- Peak concentration（Cmax）(2 years)
- Time to peak（Tmax）(2 years)
- Immunogenicity(2 years)
- Progression free survival(PFS)(2 years)
- Overall survival (OS)(2 years)
- Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)(2 years)
Investigators
Study Sites (1)
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