Clinical trial · Interventional
The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
NCT06022250CI-TRIAL-00116635active not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Malignant Tumor | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JS207 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JS207
- interventionNames
- Drug: JS207
Primary outcomes (2)
- 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
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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；
References
Publications (0)
Data not yet available
No reference posted for this study.