A First-in-Human, Open Label, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Antitumor Activity 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:

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

Exclusion Criteria:

1. Receive treatment before study as below:

   a) Previous systematic anti-cancer therapy;

2. Active or prior documented autoimmune disease within past 2 years;

3. History of clinically significant cardiovascular disease;

4. Significant acute or chronic infections;

5. Prior toxicities from anti-cancer therapies have not regressed to grade ≤1 severity;

6. Any prior Grade≥3 irAE while receiving immunotherapy;

7. Unstable brain metastasis or meningeal metastasis with clinical symptoms;

8. Patients with mental disorders or poor compliance;

9. Known alcohol or drug abuse;

10. Other severe systemic diseases or conditions that unsuitable for participating in this study in the opinion of the investigator.

Open Label