The main purpose To evaluate the safety, tolerability, and pharmacokinetic characteristics of SIBP-A18 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
A secondary purpose To preliminarily evaluate the anti-tumor efficacy of SIBP-A18. Evaluate the effect of SIBP-A18 injection on Q to T interval/Corrected QT interval (QT/QTc interval) in participants with advanced solid tumors
Age range from 18 to 75 years old (including boundary values), regardless of gender.
Dose escalation and dose expansion stage: Patients with advanced solid tumor diagnosed by histology and/or cytology, who have previously failed standard treatment, lack standard treatment regimens, are intolerant to standard treatment, or are currently not eligible for standard treatment.
Willing and able to provide sufficient fresh collected or archived tumor tissue samples within two years.
At least one measurable lesion must be selected as the target lesion (according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 standard, computed tomography (CT) or magnetic resonance imaging (MRI)) (for lesions that have previously received radiotherapy, only with clear progression can they be selected as the target lesion).
The participant has had other malignant tumors that have not been cured within the past 5 years (excluding malignant tumors that have been clearly cured, such as thyroid cancer, cured basal cell carcinoma of the skin, and cervical carcinoma in situ).
The participant has untreated imaging confirmed central nervous system metastasis.
Meningeal metastases.
Patients with brain metastases who have received systematic or curative brain metastasis treatment (radiotherapy or surgery) in the past, have been confirmed stable by imaging for at least 4 weeks, and have stopped systemic hormone, antiepileptic, convulsive drugs, and other treatments for more than 2 weeks without clinical symptoms can be enrolled.
Single group
SIBP-A18
DrugSIBP-A18 formulation for injection, Claudin18.2-ADC. Strength: 1.0, 2.0, 3.2, 4.0, 4.8, 5.6, 6.4 and 8.0 mg/kg. 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 participant. 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. The third stage will use RP2D for further exploration.
Adverse Events (AE)
That is adverse events, any adverse events that occurred to the participant during the study period.
Serious Adverse Events (SAE)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
Area Under The Plasma Concentration Versus Time Curve (AUC)
It shows the degree to which a drug is absorbed and used in the body.
Peak Plasma Concentration (Cmax)
It shows the highest plasma concentration of a drug that can be achieved after administration.
Objective Response Rate (ORR)
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.
Disease control rate (DCR)
In clinical trials, the percentage of participants with advanced cancer who responded fully to cancer treatment, partially responded, and had stable disease.
Progression-free survival (PFS)
The time between the onset of randomization and the onset (of any aspect) of tumor progression or death (from any cause).
overall survival (OS)
From randomization to time of death due to any cause.
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