To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A17 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Age range of 18 to 75 years old (including boundary values), gender not limited.
Cohort 1: Late/unresectable and/or metastatic breast cancer with low HER2 expression (IHC1+or IHC2+/FISH -) after standard treatment failure or intolerance.
Cohort 2: HER2 positive (IHC3+or IHC2+and FISH+) local advanced or metastatic digestive system tumors that fail or are not tolerated after standard treatment, including adenocarcinoma of stomach or gastroesophageal junction, colorectal cancer, etc. (pancreatic cancer and biliary tract cancer are excluded).
Cohort 3: HER2 positive (IHC3+or IHC2+with FISH+) advanced gynecological tumors that have failed or are intolerant to standard treatment, including but not limited to cervical cancer, endometrial cancer, and ovarian cancer.
Patients with tumors as specified in the protocol
Individuals with a history of previous treatment or surgery, or those who have received anti-tumor treatment as specified in the protocol during the planned trial period.
Individuals with a history of previous illnesses or abnormal conditions as specified in the laboratory examination protocol.
Screening for individuals with positive Treponema pallidum antibodies during the screening period. Individuals with active hepatitis B virus (HBV) or hepatitis C virus (HCV).
Single group
SIBP-A17
DrugStrength: 1, 2, 4, 5, 6 or 8 mg. Intravenous infusion administration, with a treatment cycle of every 21 days, administered once on the first day of each cycle. The dose escalation stage, 1mg/kg and 2mg/kg were subjected to accelerated titration, where the safety was evaluated within 21 days after the first administration to one subject. If dose-limiting toxicity (DLT) occurred, the traditional "3+3" dose escalation method was immediately switched. If DLT does not occur, the next dose group will be explored, and the dose exploration starting from 4mg/kg will adopt a "3+3" dose escalation design.
Dose limiting toxicity (DLT)
During the dose escalation phase, the first treatment cycle (21 days after the first dose) after the subject's administration was determined by the investigator to have occurred events related to the investigational drug as specified in the protocol.
Maximum tolerated dose (MTD)
The maximum tolerated dose (MTD) refers to the highest dose at which DLT does not occur in \<1/3 of subjects or ≤ 1/6 of subjects during the DLT observation period.
Recommended Phase II Dose (RP2D)
Recommended Phase II Dose The optimal dose for phase II clinical trial research obtained based on clinical trial results of phase I and literature review.
Adverse Events (AE)
That is adverse events, any adverse events that occurred to the participant during the study period.
AUC (Area Under The Plasma Concentration Versus Time Curve)
It shows the degree to which a drug is absorbed and used in the body.
Cmax (Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
ORR(Objective Response Rate)
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.
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.
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