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

Phase 1

Recruiting

• Conditions: Advanced Malignant Tumor
• Interventions: Drug: JS207

• Registration Number: NCT06022250
• Lead Sponsor: Shanghai Junshi Bioscience Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-01
• Study Start: 2023-09-26
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 192

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
JS207	JS207	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity （DLT）、adverse event（AE）	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	2 Years	Maximum tolerated dose (MTD), Recommended dose for phase II trial

Secondary Outcome Measures

Name	Time	Method
Elimination half life（t1/2）	2 years	The time it takes the blood to reduce the concentration of the drug to half
Peak concentration（Cmax）	2 years	The highest plasma drug concentration that can be achieved after medication
Time to peak（Tmax）	2 years	After a single dose, the time of peak blood concentration
Immunogenicity	2 years	Incidence of Anti-Drug Antibody (ADA)
Progression free survival(PFS)	2 years	The time from first dose to Disease progression or death
Overall survival (OS)	2 years	The time from first dose to death from any cause
Objective response rate (ORR) based on Response Evaluation Criteria In Solid Tumors 1.1 (RECIST1.1)	2 years	Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Shandong First Medical University; 🇨🇳 Jinan, Shandong, China