NCT06990464

A Clinical Trial of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients

A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIBP-A19 Injection in the Treatment of Advanced Malignant Solid Tumor Patients

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 156 (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, and pharmacokinetic characteristics of SIBP-A19 and determine the maximum tolerable dose (MTD) and phase II recommended dose (RP2D).

Detailed description

This study is an open label, multicenter, 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-A19 for injection in participants with advanced or metastatic solid tumors. This study is divided into three stages and is planned to be set up eight dose groups, including 1.0, 2.0, 3.2, 4.0, 4.8, 5.6, 6.4 and 8.0 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. The second stage is the dose expansion stage, where two or more doses are selected to enter the dose expansion phase, and 6-9 participants 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, the investigators plan to expand three indication cohorts, with at least 30 participants selected for each cohort.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	SIBP-A19	SIBP-A19 formulation for injection. 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.

Timeline

• Start date: 2025-06-11
• Primary completion: 2028-12-15
• Completion: 2028-12-15
• First posted: 2025-05-25
• Last updated: 2026-01-08

Locations

1 site across 1 country: China