Clinical Trial of BT02 in Patients With Advanced Solid Tumors

Overall study design:

This is an open-label, FIH, Phase I / II study of BT02 to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of BT02 in adult patients with advanced solid tumors.

Inclusion criteria

• Age ≥18 at the time of signing the informed consent form, male or female;
• Patients must have histologically or cytologically confirmed diagnosis of advanced solid tumor;
• Adequate organ and hematologic function;
• Patients must have at least measurable or evaluable lesion in phase I and measurable lesion in phase II according to RECIST 1.1;
• ECOG performance status 0~1;
• Life expectancy ≥ 3 months;
• Good compliance and be willing to follow-up visit.

Exclusion criteria

• Receive treatment before study as below:

a) Previous systematic anti-cancer therapy;

• Active or prior documented autoimmune disease within past 2 years;
• History of clinically significant cardiovascular disease;
• Significant acute or chronic infections;
• Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;
• Any prior Grade≥3 irAE while receiving immunotherapy;
• Unstable brain metastasis or meningeal metastasis with clinical symptoms;
• Patients with mental disorders or poor compliance;
• Known alcohol or drug abuse;
• Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.