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 enrollmentSeptember 26, 2023

ConditionsAdvanced Malignant Tumor

InterventionsJS207

DrugsJS207

Overview

Phase: Phase 1
Intervention: JS207
Conditions: Advanced Malignant Tumor
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
Enrollment: 98
Locations: 1
Primary Endpoint: Dose-limiting toxicity （DLT）、adverse event（AE）
Status: Active, not recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 26, 2023

End Date

June 30, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Intervention: JS207

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)