NCT05650203

A Study of JS009 Monotherapy and JS009 as a Triple Combination Therapy in Patients With Advanced Malignancies

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of JS009 Monotherapy and JS009 as a Triple Combination Therapy in Combination With Toripalimab and JS006 in Patients With Advanced Malignancies

• Status: Withdrawn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

The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy JS009 as a monotherapy and JS009 as a Triple Combination Therapy in Combination with Toripalimab and JS006 in Patients with Advanced Malignancies, also to explore the RP2D of JS009.

Detailed description

This is an open-label, Phase I study contains dose escalation phase, dose expansion phase and indication expansion phase. The dose escalation phase will be following the accelerated titration design and the classic 3+3 design, with a planned enrollment of 13 to 30 patients with advanced tumors. The dose expansion phase will be used safe and tolerable doses, with a planned enrollment of 9 to 24 patients with advanced tumors. The indication expansion phase will selecte different primary malignancies for investigation of anti-tumor activity. Each Cohort planned to enrollment 20-50 patients with advanced tumors.

Conditions

• Primary Condition: Advanced Tumors

Interventions

Type	Name	Description
DRUG	JS009 as a monotherapy and JS009 as a Triple Combination Therapy in Combination with Toripalimab and JS006	1. JS009 as Monotherapy in first cycle of dose escalation and as the triple combination therapy will be administered in subsequent cycles：JS009,18mg/60mg/180mg/600mg/1200mg, JS006, fixed dose 600mg, Toripalimab injection fixed dose 240mg,IV infusion, every 3 weeks (q3w). 2. Triple combination therapy in dose expansion：JS009, 1 or 2 specific dose, with fixed dose of JS006 and Toripalimab Injection, IV infusion, every 3 weeks (q3w). 3. Triple combination therapy in indication expansion：JS009, 1 specific dose, with fixed dose of JS006 and Toripalimab Injection, IV infusion, every 3 weeks (q3w).

Timeline

• Start date: 2023-03-31
• Primary completion: 2025-10-25
• Completion: 2026-12-31
• First posted: 2022-12-14
• Last updated: 2023-04-05