A Phase I, Multi-center, Open-label Study with Dose-escalation and Multiple Expansion Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of JYB1907 in Subjects with Advanced Solid Tumors
Dose escalation This part is meant to evaluate the safety, tolerability, PK, immunogenicity, preliminary antitumor activity, the MTD and RP2D of JYB1907 in patients with histologically or cytologically confirmed advanced solid tumors. Expansion cohort The antitumor activity, safety, tolerability, PK and immunogenicity of JYB1907 will be further evaluated in other cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
for injection
Adverse events
Adverse events, and changes from baseline in vital signs,etc.
Time frame: until either 28 days after last dose of study drug or initiation of new anticancer therapy, whichever occurs first.
Serum concentrations of JYB1907
JYB1907 assessed by pre-specified methods, and related pharmacokinetic parameters analysis
Time frame: until 28 days after last dose of study drug
Serum concentrations of Immunogenicity Analysis
immunogenicity of JYB1907 assessed by pre-specified methods, and related immunogenic features analysis
Time frame: until 28 days after last dose of study drug
Serum concentrations of Preliminary antitumor activity
To evaluate the preliminary antitumor activity of JYB1907 in patients with advanced solid tumors assessed by Recist1.1
Time frame: until 28 days after last dose of study drug
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