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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

the main purpose:

• Evaluate the safety and resistance of BAT6026 injection as a single agent in the treatment of patients with locally advanced or metastatic solid tumors Acceptability

• Explore maximum tolerated dose (MTD) or maximum administered dose (MAD) and be phase II or follow-up clinical The study provides recommended doses and reasonable dosing schedules.

Secondary purpose:

• Evaluate the single dose and multiple doses of BAT6026 injection in patients with locally advanced or metastatic solid tumors Pharmacokinetic (PK) characteristics of the drug;

• Evaluate the immunogenicity of BAT6026 injection;

• Evaluate the pharmacodynamic properties of BAT6026 injection;

• Preliminary evaluation of the anti-tumor efficacy of BAT6026 injection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bio-Thera Solutions

Criteria

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;