NCT05128539

A Study Explore JS001+JS002 in Patients With Advanced Cancer

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Humanized Anti-PCSK9 Monoclonal Antibody (JS002) Combined With Toripalimab in Patients With Advanced Cancer

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Shanghai Junshi Bioscience Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This open-label phase I clinical study with clinical development phase will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JS002 combined with Toripalimab in advanced cancer patients, who has failed standard therapy OR could not tolerate standard therapy OR refused/had no standard therapy. This study is divided into two parts: Part A. JS002 combined with Toripalimab dose escalation and dose expansion phase; Part B.JS002 combined with Toripalimab clinical expansion phase.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	JS001(Toripalimab)+JS002	Part A: In this phase, 3 dose levels will be preliminarily set up. The dose level of Toripalimab is fixed as 240 mg, intravenous infusion, Q3W. The dose levels of JS002 are fixed at 75 mg,150 mg and 300 mg subcutaneously, and the traditional 3+3 design will be used for dose escalation with 21 days as entire treatment cycle. In addition, the period of 21 days after the first administration is defined as the DLT observation period. Part B: Based on the data of the safety, PK and preliminary efficacy in Part A patients, the dosage will be determined for advanced tumor patients who had received at least first-line therapy in this part. Two to three groups with different tumor types will be further enrolled, and about 30 patients will be included in each group (the specific number and cohort will be adjusted according to the research progress). Toripalimab is a humanized IgG4κ mAb specific against human PD-1.

Timeline

• Start date: 2022-02-10
• Primary completion: 2023-11-10
• Completion: 2023-11-10
• First posted: 2021-11-22
• Last updated: 2024-03-26

Locations

1 site across 1 country: China