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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06022250
Other study ID # JS207-001-I
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date September 15, 2023
Est. completion date March 15, 2026

Study information

Verified date August 2023
Source Shanghai Junshi Bioscience Co., Ltd.
Contact Kai Xu
Phone 86 13761020175
Email kai_xu@junshipharma.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 162
Est. completion date March 15, 2026
Est. primary completion date September 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
JS207
Patients will receive specific dose of JS207 via intravenous infusion.

Locations

Country Name City State
China Affiliated Cancer Hospital of Shandong First Medical University Jinan Shandong

Sponsors (2)

Lead Sponsor Collaborator
Shanghai Junshi Bioscience Co., Ltd. Sponsor GmbH

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dose-limiting toxicity (DLT)?adverse event(AE) Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance 2 Years
Primary Maximum tolerated dose (MTD),RP2D Maximum tolerated dose (MTD), Recommended dose for phase II trial 2 Years
Secondary Peak concentration(Cmax) The highest plasma drug concentration that can be achieved after medication 2 years
Secondary Time to peak(Tmax) After a single dose, the time of peak blood concentration 2 years
Secondary Elimination half life(t1/2) The time it takes the blood to reduce the concentration of the drug to half 2 years
Secondary Progression free survival(PFS) The time from first dose to Disease progression or death 2 years
Secondary Overall survival (OS) The time from first dose to death from any cause 2 years
Secondary Immunogenicity Incidence of Anti-Drug Antibody (ADA) 2 years
Secondary Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1) Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR) 2 years
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