A Safety Study of YQ23 in Advanced Solid Tumors Patients

Summary

This is an early phase dose escalation study which is divided into two stages: (1) Single agent of the test drug YQ23, and (2) in combination with pembrolizumab administered to patients with advanced solid tumors. The purpose of the study is find out the safety and tolerability profile, as well as maximum tolerated dose (MTD) of YQ23 as single agent (stage 1) and in combination with pembrolizumab (stage 2). Stage 2 will start only when the MTD of single agent YQ23 has been established in Stage 1. The distribution of YQ23 in the blood, the tumor response to YQ23 (and pembrolizumab in stage 2), the change of some pre-defined biomarkers in the tumor tissues and blood, and the change of antibody response and its relationship with the disease response, safety and drug level in the blood will also be evaluated. In stage 1, eligible patients will be given intravenous infusion of YQ23 weekly for 6 weeks. In stage 2, eligible patients will be also be given a fixed dose of pembrolizumab 200 mg on Day 1 and every 3 weeks thereafter in addition to the weekly dose of YQ23. Dose escalation decision will be made based on the safety data available for the 6 weeks study treatment(s). Patients may continue study treatment(s) beyond 6 weeks if s/he tolerates the study drug(s) well, the disease does not get worse after first 6 doses and meet all treatment continuation criteria, as judged by the study doctor.

Timeline

Start

2020-08-21

Primary completion

2023-07-26

Completion

2023-07-26

Outcome

Outcome not reported

Stopped (Business): “Due to business decision”

Drugs

Indications