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

NCT ID: NCT06022250

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 98 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-26
• Study Completion Date: 2026-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JS207

Group Type: EXPERIMENTAL

JS207

Intervention Type: DRUG

Patients will receive specific dose of JS207 via intravenous infusion.

Interventions

JS207

Patients will receive specific dose of JS207 via intravenous infusion.

Intervention Type: DRUG

Eligibility Criteria

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；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sponsor GmbH

OTHER

Sponsor Role: collaborator

Shanghai Junshi Bioscience Co., Ltd.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

Countries

China

Other Identifiers

JS207-001-I

Identifier Type: -

Identifier Source: org_study_id