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

Advanced Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06022250
• Other study ID #: JS207-001-I
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 15, 2023
• Est. completion date: March 15, 2026

Study information

• Verified date: August 2023
• Source: Shanghai Junshi Bioscience Co., Ltd.
• Contact: Kai Xu
• Phone: 86 13761020175
• Email: kai_xu[@]junshipharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: March 15, 2026
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignant Tumor
• Neoplasms

Intervention

Drug:
• JS207
Patients will receive specific dose of JS207 via intravenous infusion.

Locations

Country	Name	City	State
China	Affiliated Cancer Hospital of Shandong First Medical University	Jinan	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Junshi Bioscience Co., Ltd.	Sponsor GmbH

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Maximum tolerated dose (MTD),RP2D	Maximum tolerated dose (MTD), Recommended dose for phase II trial	2 Years
Secondary	Peak concentration(Cmax)	The highest plasma drug concentration that can be achieved after medication	2 years
Secondary	Time to peak(Tmax)	After a single dose, the time of peak blood concentration	2 years
Secondary	Elimination half life(t1/2)	The time it takes the blood to reduce the concentration of the drug to half	2 years
Secondary	Progression free survival(PFS)	The time from first dose to Disease progression or death	2 years
Secondary	Overall survival (OS)	The time from first dose to death from any cause	2 years
Secondary	Immunogenicity	Incidence of Anti-Drug Antibody (ADA)	2 years
Secondary	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