Phase I Study to Assess the Safety, Dosage, and Early Effectiveness of SIBP-A18 Injection for Adults with Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of SIBP-A18, an investigational drug, in patients with advanced solid tumors. The study aims to determine the maximum tolerable dose and recommended dose for further research, while also preliminarily assessing its anti-tumor effects and impact on heart electrical activity in this patient group. This is a phase I clinical trial sponsored by the Shanghai Institute Of Biological Products. The study consists of three stages involving multiple dose groups ranging from 1.0 to 8.0 mgkg. Participants receive SIBP-A18 by intravenous infusion once every 21 days. The first stage focuses on dose escalation using an accelerated or traditional 33 method. The second stage expands dosing to enroll 6-9 participants per dose group, and the third stage explores the recommended dose in three specific cancer cohorts with at least 30 participants each. Participants will be monitored for adverse events, drug levels in the blood, and other pharmacokinetic measures at defined intervals up to 63 days after the first dose. Researchers will also assess tumor response, disease control, progression-free survival, and overall survival approximately 6 weeks after the last evaluation. Safety evaluations continue from the first dose through 28 days after the final dose, ensuring close follow-up during treatment.

A Clinical Trial of SIBP-A18 Injection in the Treatment of Advanced Malignant Solid Tumor Patients