To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A13 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
This study is an open, multi-dose increasing single and multiple doses increasing, dose expanding, and indication expanding study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, preliminary anti-tumor efficacy, and explore potential biomarkers of SIBP-A13 in patients with advanced solid tumors. This study is divided into three stages and is planned to be set up six dose groups, including 1, 2, 4, 5, 6, and 8 mg/kg. The first stage is the dose escalation stage, with a planned enrollment of 16-36 participants. The second stage is the dose expansion stage, where two doses are selected to enter the dose expansion phase. 6-9 late-stage solid tumor participants are enrolled in each dose group for dose expansion, and 12-18 participants are planned to be enrolled in the dose expansion phase. The third stage is the indication expansion stage, where phase II recommended dose (RP2D) is preliminarily determined based on the escalation and expansion of dosage in the early stage. Using RP2D for indication expansion, we plan to expand three indication cohorts, with at least 30 participants selected for each cohort.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
SIBP-A13: injection; strength: 1, 2, 4, 5, 6 or 8 mg; dose escalation and the first group is 1mg (intravenous infusion). Starting from the lowest dose, when the former does not meet the termination criteria, then start the next dose group study until Maximum Tolerated Dose (MTD). The study adopts a "3+3" dose increasing design. Administration period: divided into single administration and multiple administration. Single dose administration: The participants are administered a single dose on the first day for a total of 21 days of observation, and complete the examinations and evaluations specify in the protocol. If dose-limiting toxicity (DLT) does not occur, the participant enters a multiple dosing period. Multiple administration: administration every 3 weeks.
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGAE (Adverse Events)
That is adverse events, any adverse events that occurred to the participant during the study period.
Time frame: 28 days after the last dose
SAE (Serious Adverse Events)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Time frame: 28 days after the last dose
AUC (Area Under The Plasma Concentration Versus Time Curve)
It shows the degree to which a drug is absorbed and used in the body.
Time frame: 18 weeks after the first dose
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Time frame: 18 weeks after the first dose
Tmax (Peak Time)
That is peak time of drug action, it shows the time required to reach the maximum concentration on the participant plasma concentration curve after administration.
Time frame: 18 weeks after the first dose
T ½ (Terminal elimination half-life)
It reflects how quickly the drug is eliminated from the body.
Time frame: 18 weeks after the first dose
CL (Clearance Rate)
Apparent volume of drug distribution removed from the body per unit time.
Time frame: 18 weeks after the first dose
ORR (Objective Response Rate)
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The proportion of participants whose tumor volume shrinks to a predetermined value and maintains the minimum time limit and is the sum of complete and partial responses.
Time frame: 7 days after the last dose
DCR (Disease control rate)
In clinical trials, the percentage of participants with advanced or metastatic cancer who responded fully to cancer treatment, partially responded, and had stable disease.
Time frame: 7 days after the last dose
PFS (Progression-free survival)
The time between the onset of randomization and the onset (of any aspect) of tumor progression or death (from any cause).
Time frame: 7 days after the last dose
OS (overall survival)
From randomization to time of death due to any cause.
Time frame: 7 days after the last dose