The Recombinant Humanized Anti-TIGIT Monoclonal Antibody (JS006) Monotherapy and in Combination With Toripalimab in Patients With Advanced Tumor

Phase 1

Recruiting

• Conditions: Advanced Tumors
• Interventions: Drug: JS006 as Monotherapy; Drug: JS006 in combination with Toripalimab

• 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

Study Timeline

• Study Start: 2021-04-21
• Status Verified: 2021-08
• Study First Submitted: 2021-08-19
• Study First Submitted QC: 2021-09-21
• Last Update Submitted: 2021-09-21
• Study First Posted: 2021-09-29
• Last Update Posted: 2021-09-29
• Primary Completion: 2023-08-14
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 176

Inclusion Criteria

Not provided

Exclusion Criteria

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