Clinical Trials Directory

Trials / Unknown

UnknownNCT05061628

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

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

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

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.

Conditions

Interventions

TypeNameDescription
DRUGJS006 as Monotherapy1. JS006 as Monotherapy dose-escalation: JS006, 18/ 60/ 180/ 600/ 1800mg, IV infusion, every 3 weeks (q3w). 2. JS006 as Monotherapy dose-extension: JS006, 1 or 2 specific dose, IV infusion, every 3 weeks (q3w).
DRUGJS006 in combination with Toripalimab1. JS006 in combination with Toripalimab dose-escalation: JS006, 2 or 3 specific dose, IV infusion, every 3 weeks (q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). 2. JS006 in combination with Toripalimab dose-extension: JS006, 1 or 2 specific dose, IV infusion, every 3 weeks (q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). 3. JS006 in combination with Toripalimab indications expansion: JS006, RP2D, IV infusion, every 3 weeks(q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w).

Timeline

Start date
2021-04-21
Primary completion
2023-08-14
Completion
2024-09-30
First posted
2021-09-29
Last updated
2021-09-29

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05061628. Inclusion in this directory is not an endorsement.