A Clinical Study of TAB006 in Patients With Previously Treated, Advanced Malignancies
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
Outcome
Outcome not reported
Stopped: “transfer the study to another sponser”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TAB006 | Monoclonal antibody | 18 mg | Intravenous |
| Subject | TAB006 | Monoclonal antibody | 60 mg | Intravenous |
| Subject | TAB006 | Monoclonal antibody | 180 mg | Intravenous |
| Subject | TAB006 | Monoclonal antibody | 240 mg | Intravenous |
| Subject | TAB006 | Monoclonal antibody | 600 mg | Intravenous |
| Subject | TAB006 | Monoclonal antibody | 1800 mg | Intravenous |
| Subject | Toripalimab | Monoclonal antibody | 240 mg | Intravenous |