drugset / Trial / NCT05262842

JS001+IMP4297 in Patients With Advanced Cancer

NCT05262842

NaSingle-groupOpen-labelTreatment

Summary

This is a Phase I/Ib open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity and antitumor activity of toripalimab in combination with senaparib in patients with advanced solid tumors. The study consists of 2 parts, the Phase I part of the study will be a dose-escalation evaluation to determine the RP2D of senaparib to be administered in combination with the fixed dose of toripalimab, and the Phase Ib portion will further evaluate the RP2D and evaluate the efficacy of combination in specific types of advanced solid tumors.

Timeline

Start
2022-03-29
Primary completion
2024-04-06
Completion
2024-06-06

Drugs

EvaluationDrugModalityDoseRoute
Subject IMP4297 Unknown 60 mg
Subject IMP4297 Unknown 80 mg
Subject IMP4297 Unknown 100 mg
Subject Toripalimab Monoclonal antibody 240 mg