Affiliated Cancer Hospital of Shandong First Medical University
Jinan, Shandong, 250117, China
NCT Number: NCT06022250
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Interventional
Phase 1
Jinan, Shandong, 250117, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive specific dose of JS207 via intravenous infusion.
Time frame: 2 Years
Incidence and severity of DLT, adverse events (AE), Abnormal changes in laboratory and other tests with clinical significance
Time frame: 2 Years
Maximum tolerated dose (MTD), Recommended dose for phase II trial
Time frame: 2 years
The highest plasma drug concentration that can be achieved after medication
Time frame: 2 years
After a single dose, the time of peak blood concentration
Time frame: 2 years
The time it takes the blood to reduce the concentration of the drug to half
Time frame: 2 years
The time from first dose to Disease progression or death
Time frame: 2 years
The time from first dose to death from any cause
Time frame: 2 years
Incidence of Anti-Drug Antibody (ADA)
Time frame: 2 years
Defined as the proportion of subjects who achieved partial response (PR) or complete response (CR)
Shanghai Junshi Bioscience Co., Ltd.
Other
A Phase I Study to Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of JS207 in Patients With Advanced Malignant Tumor
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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