The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor

NCT06022250 | Active Not Recruiting Phase 1

• 1 other identifier: JS207-001-I
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Tumor

Outcome Measures

Primary Outcomes (2)

• 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

• Maximum tolerated dose (MTD),RP2D

  Maximum tolerated dose (MTD), Recommended dose for phase II trial

  2 Years

Secondary Outcomes (7)

• Peak concentration（Cmax）

  2 years

• Time to peak（Tmax）

  2 years

• Elimination half life（t1/2）

  2 years

• Progression free survival(PFS)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

JS207

EXPERIMENTAL

Drug: JS207

Interventions

JS207 DRUG

Patients will receive specific dose of JS207 via intravenous infusion.

JS207

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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；

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead
• Sponsor GmbH: collaborator

Study Sites (1)

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, 250117, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: September 1, 2023
• Study Start: September 26, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)