The Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumor
- Conditions
- Advanced Tumors
- Interventions
- Drug: JS006 as Monotherapy
- Registration Number
- NCT05061628
- Lead Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 176
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description JS006 as Monotherapy 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. JS006 in combination with Toripalimab 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.
- Primary Outcome Measures
Name Time Method 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 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 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 Outcome Measures
Name Time Method To determine the immunogenicity of JS006 as monotherapy and in combination with toripalimab in patients with advanced tumors 2 years Immunogenicity: incidence of anti-drug antibodies (ADAs) and/or neutralizing antibodies (Nabs) of JS006 and toripalimab.
Pharmacokinetic (PK) profile: JS006 2 years JS006 concentrations in individual subjects at different time points after dosing of JS006.
Duration of response (DOR) 2 years The time from the first assessment of CR or PR to the first assessment of PD or death due to any cause.
Overall survival (OS) 2 years Overall survival is defined as time from the start of treatment until death due to any reason.
Within 1 hour before the first administration to 90 ±7 days after the last administration. 2 years Peripheral blood immune cell subset and receptor occupancy of TIGIT
Disease control rate (DCR) 2 years The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
Time to response (TTR) 2 years time from the start of treatment to progression of diease.
Objective response rate (ORR) 2 years The percentage of cases with remission (PR + CR) after treatment was assessable.
Progression-free survival (PFS) 2 years PFS is defined as time from the start of treatment to progression of disease or death.
Trial Locations
- Locations (1)
Sun Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China