Clinical Trials in China / NCT06022250
Active, not recruiting
Phase 1
The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
NCT06022250 · tracked via the Priya Life Science China tracker
Condition(s) studied
Advanced Malignant Tumor
Investigational drug(s) / intervention(s)
JS207: Patients will receive specific dose of JS207 via intravenous infusion.
Study 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.
Eligibility
Inclusion Criteria:
1. Patients with advanced malignant tumor confirmed by histology or pathology, failed by standard treatment, no standard treatment or no standard treatment is applicable;
2. Eastern Cooperative Oncology Group (ECOG) 0 or 1;
3. Life expectancy ≥ 12 weeks;
4. At least one measurable lesion according to RECIST 1.1;
5. Adequate organ function;
Exclusion Criteria:
1. central nervous system metastasis；
2. There is a pleural, abdominal or pericardial effusion that is clinically symptomatic or requires repeated management (puncture or drainage, etc.)；
3. 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；
4. The presence of severe, unhealed or open wounds, active ulcers, or untreated fractures；
5. A history of significant bleeding tendency or severe coagulopathy；
6. The presence of poorly controlled hypertension；
Primary outcome measure(s)
- Dose-limiting toxicity （DLT）、adverse event（AE） — 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 — 2 Years
Maximum tolerated dose (MTD), Recommended dose for phase II trial
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Affiliated Cancer Hospital of Shandong First Medical University | Jinan | Shandong |
More Shanghai Junshi Bioscience Co., Ltd. trials in China
JS207Combined With Chemotherapy in First-line Treatment of Advanced NSCLC
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06022250 on ClinicalTrials.gov ↗ ← All trials in China