A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Initial Efficacy of Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumors
Overview
- Phase
- Phase 1
- Intervention
- JS006 as Monotherapy
- Conditions
- Advanced Tumors
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Determing the maximum tolerated dose and the recommended phase II dose for JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
This is an open-label, dose-escalation and dose-expansion phase I clinical study to evaluate the safety and tolerability of JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors who have failed standard therapies or who have no standard therapy. It is planned to enroll 69-176 patients into the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
JS006 as Monotherapy
1. JS006 as Monotherapy dose-escalation：5 proposed dose levels（18mg, 60mg, 180mg, 600mg, 1800mg). 2. JS006 as Monotherapy dose-extension：1 or 2 proposed dose levels, to be determined.
Intervention: JS006 as Monotherapy
JS006 in combination with Toripalimab
1. JS006 in combination with Toripalimab dose-escalation：2 or 3 proposed dose levels, to be determined. 2. JS006 in combination with Toripalimab dose-extension：1 or 2 proposed dose levels, to be determined. 3. JS006 in combination with Toripalimab indications expansion: 2 to 4 specific tumor types are selected for indication expansion after the combination dose-expansion is completed.
Intervention: JS006 in combination with Toripalimab
Outcomes
Primary Outcomes
Determing the maximum tolerated dose and the recommended phase II dose for JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors
Time Frame: 2 years
Maximum tolerated dose: Dose Limitted Toxictiy events occurred at a rate less than 1/3 of the maximum tolerated dose. Phase II recommended dose: safety, pharmacokinetics, and preliminary efficacy data of dose escalation will be integrated. When the Maximum tolerated dose(MTD) is determined, the Maximum tolerated dose(MTD) is usually used as the Phase II recommended dose(RP2D), or the dose lower than the Maximum tolerated dose(MTD) is selected as the Phase II recommended dose(RP2D) based on the comprehensive data.
To evaluate the safety and tolerability of JS006 as Monotherapy and in combination with toripalimab in patients with advanced tumors
Time Frame: 2 years
Incidence and severity of dose limiting toxicity (DLT), adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs); abnormal changes with clinical significance in the laboratory and other tests
Secondary Outcomes
- To determine the immunogenicity of JS006 as monotherapy and in combination with toripalimab in patients with advanced tumors(2 years)
- Pharmacokinetic (PK) profile: JS006(2 years)
- Duration of response (DOR)(2 years)
- Overall survival (OS)(2 years)
- Within 1 hour before the first administration to 90 ±7 days after the last administration.(2 years)
- Disease control rate (DCR)(2 years)
- Time to response (TTR)(2 years)
- Objective response rate (ORR)(2 years)
- Progression-free survival (PFS)(2 years)