NCT07205198

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Shanghai Institute Of Biological Products · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety, tolerability of SIBP-A10 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Detailed description

This study is an open label, dose escalation, dose expansion, and indication expansion study to evaluate safety, tolerability, pharmacokinetics, preliminary anti-tumor efficacy, immunogenicity, impact on QT/QTc interval, and explore potential biomarkers of SIBP-A10 for injection in subjects with advanced metastatic tumors. This study is divided into three stages and is planned to be set up seven dose groups, including 0.5, 1.5, 3, 5, 7, 10 and 15 mg/kg. The first stage is the dose escalation stage, which will start from the first and second doses for enrollment. If necessary, a 3+3 dose escalation design will be used. At least 19 subjects will be enrolled, and the specific sample size should be adjusted according to the subjects' tolerance level. The second stage is the dose expansion stage, where two or more doses are selected to enter the dose expansion phase, and at least 20 subjects will be enrolled in each dose group for dose expansion. 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 four indication cohorts, with at least 40 subjects selected for each cohort.

Conditions

• Advanced Tumors

Interventions

Type	Name	Description
DRUG	SIBP-A10	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.

Timeline

• Start date: 2025-10-31
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2025-10-03
• Last updated: 2026-01-08

Locations

1 site across 1 country: China