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drugset / Trial / NCT05253105

A Clinical Study of TAB006 in Patients With Previously Treated, Advanced Malignancies

NCT05253105 ↗

Phase 1 Withdrawn Shanghai Junshi Bioscience Co., Ltd. CTI Clinical Trial and Consulting Services · collabTopAlliance Biosciences · collab
Non-randomizedSequentialOpen-labelTreatment

Summary

The primary objective is to assess the safety and tolerability of TAB006 as monotherapy and in combination with toripalimab in subjects with selected advanced solid malignancies, including lymphoma, and to evaluate the recommended Phase 2 dose. The secondary objectives are to: 1) describe the pharmacokinetic (PK) profile of TAB006 monotherapy and in combination with toripalimab and to describe the PK profile of toripalimab when administered with TAB006, 2) evaluate antitumor activity of TAB006 monotherapy and in combination with toripalimab; and 3) determine the immunogenicity of TAB006 monotherapy and in combination with toripalimab and to determine the immunogenicity of toripalimab when administered with TAB006.

Timeline

Start
2022-03-15
Primary completion
2026-09
Completion
2027-01

Drugs

EvaluationDrugModalityDoseRoute
Subject JS006 Monoclonal antibody 18 mg Intravenous
Subject JS006 Monoclonal antibody 60 mg Intravenous
Subject JS006 Monoclonal antibody 180 mg Intravenous
Subject JS006 Monoclonal antibody 240 mg Intravenous
Subject JS006 Monoclonal antibody 600 mg Intravenous
Subject JS006 Monoclonal antibody 1800 mg Intravenous
Subject Toripalimab Monoclonal antibody 240 mg Intravenous

Indications

cancer