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

A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Advanced Malignant Tumor
• Intervention / Treatment: Drug: JS207

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250117
      • Affiliated Cancer Hospital of Shandong First Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JS207	Drug: JS207; Patients will receive specific dose of JS207 via intravenous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum tolerated dose (MTD),RP2D	Maximum tolerated dose (MTD), Recommended dose for phase II trial	2 Years
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak concentration（Cmax）	The highest plasma drug concentration that can be achieved after medication	2 years
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
Time to peak（Tmax）	After a single dose, the time of peak blood concentration	2 years
Elimination half life（t1/2）	The time it takes the blood to reduce the concentration of the drug to half	2 years
Progression free survival(PFS)	The time from first dose to Disease progression or death	2 years
Overall survival (OS)	The time from first dose to death from any cause	2 years
Immunogenicity	Incidence of Anti-Drug Antibody (ADA)	2 years

Collaborators and Investigators

• Sponsor: Shanghai Junshi Bioscience Co., Ltd.
• Collaborators: Sponsor GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: August 23, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): September 1, 2023

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: JS207-001-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No