Assessment of Safety and Preliminary Efficacy With BAT6026 in Solid Tumor Patients in China

Inclusion Criteria:

1. Age: ≥18 years of age ≤75 years of age, gender: men and women are not limited;
2. The investigator estimates that the expected survival period is at least 3 months;
3. The Eastern Cooperative Oncology Group (ECOG) performance status scoring requirement is 0 or 1;
4. Patients with locally advanced or metastatic solid tumors diagnosed by pathology who have failed standard treatment or have no effective treatment methods (refer to CSCO guidelines in 2021);
5. According to the tumor efficacy evaluation standard RECIST 1.1, there must be at least one measurable tumor lesion during the dose expansion stage;

Exclusion Criteria:

1. Have received anti-OX40 monoclonal antibody or double-antibody drug therapy with anti-OX40 activity in the past;
2. It is receiving or expected to receive other anti-tumor treatments during the first study drug administration, including but not limited to chemotherapy, radiotherapy, immunotherapy, hormone therapy (except alternative therapies), targeted therapy, biological therapy, and anti-tumor effects Chinese patent medicine, etc.;
3. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time, except for the following items:? Nitrosourea or Mitomycin C is within 6 weeks before the first use of the study drug;? Oral fluorouracil and small molecule targeted drugs are 2 weeks before the first use of the study drug or 5 half-lives of the drug (whichever is longer);? Chinese medicine with anti-tumor indications should be within 2 weeks before the first use of the study drug;
4. Clinical investigators who are participating in this study or who have participated in experimental drugs or medical devices within 4 weeks before the first administration of this study cannot be included;
5. Have been vaccinated within 4 weeks before the first administration or plan to vaccinate live/attenuated vaccines and mRNA vaccines during the study period;
6. Pregnant or lactating women;
7. Patients whose AEs caused by the original anti-tumor therapy within 4 weeks before the first administration of the study drug did not return to CTCAE 5.0≤1 (except for hair loss and fatigue ≤2); previous irAE ≥3 or any level of irAE Those who have terminated immunotherapy;
8. Major surgery (defined as grade 3 and 4 surgery) within 4 weeks before the first administration;
9. Those who have a history of tissue or organ transplantation;
10. Subjects who have had serious infections within 4 weeks before the first administration, including but not limited to infectious complications that require hospitalization, bacteremia, severe pneumonia, etc.; subjects with active infections before the first administration are excluded By;