NCT05262842

JS001+IMP4297 in Patients With Advanced Cancer

A Phase Ⅰ/Ⅰb Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of Toripalimab (Anti-PD-1 Antibody) in Combination With Senaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	JS001+IMP4297	Phase I: Dose Escalation The primary endpoints are the safety and tolerability of the combination, including the incidence and nature of DLTs and the determination of the MTD and RP2D. A 3 + 3 dose-escalation (60mg,80mg,100mg)design will be used. Patient in each dose level will be treated with toripalimab 240mg in combination with senaparib. Phase Ib: Dose Expansion This part will commence after the RP2D is determined and will further evaluate the safety and anti-tumor activity of toripalimab and senaparib in patients with specific types of advanced solid tumors. Patients will be enrolled concurrently into 5 exploratory cohorts with approximately 20 patients each cohort.

Timeline

• Start date: 2022-03-29
• Primary completion: 2024-04-06
• Completion: 2024-06-06
• First posted: 2022-03-02
• Last updated: 2022-09-21