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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06022250

Enrollment

Registered

2023-09-01

Start date

2023-09-26

Completion date

2026-06-30

Last updated

2025-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignant Tumor

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.

Interventions

DRUGJS207

Patients will receive specific dose of JS207 via intravenous infusion.

Study design

Allocation

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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；

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026