A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects.
A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A10 Injection in the Treatment of Advanced Malignant Tumor Subjects
Shanghai Institute Of Biological Products
160 participants
Oct 31, 2025
INTERVENTIONAL
Conditions
Summary
To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).
Eligibility
Plain Language Summary
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Interventions
SIBP-A10 injection. Strength: 0.5, 1.5, 3, 5, 7, 10 and 15 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,0.5 mg/kg group was subjected to accelerated titration, where the safety was evaluated within 21 days after the first administration to one subject. If unacceptable toxic reactions occurred, the traditional "3+3" dose escalation method was immediately switched. If unacceptable toxic reactions do not occur, the next dose group will be explored. The third stage will use RP2D for further exploration.
Locations(1)
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NCT07205198