Assessment of Safety and Preliminary Efficacy With BAT6021 in Solid Tumor Patients in China
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
Main purpose:
- To evaluate the safety and tolerability of BAT6021 injection in the treatment of locally
advanced or metastatic solid tumors with single drug or combined with tislelizumab(anti
PD-1 monoclonal antibody);
- Explore the maximum tolerated dose (MTD) or maximum dosing dose (MAD) of BAT6021
injection monotherapy or in combination with tislelizumab and provide recommended dose
and reasonable dosing regimen for phase II or subsequent clinical studies.
Secondary purpose:
- To evaluate the pharmacokinetic (PK) characteristics of BAT6021 injection with single or
multiple doses of tislelizumab in patients with locally advanced or metastatic solid
tumors;
- Evaluate the immunogenicity of BAT6021 injection;
- To evaluate the pharmacodynamics of BAT6021 injection;
- Preliminary evaluation of the anti-tumor efficacy of BAT6021 injection alone or in
combination with tislelizumab.