drugset / Trial / NCT06056323
A Study of HB0045 Injection in Patients With Advanced Solid Tumors
Phase 1/2
Unknown
71 enrolled
Shanghai Huaota Biopharmaceutical Co., Ltd.
Dana-Farber Cancer Institute · collabGabrail Cancer Center Research · collabM.D. Anderson Cancer Center · collab
NaSequentialOpen-labelTreatment
Summary
This is a phase I/II, open-label, multicenter study . During the study, subjects will be evaluated for safety, toxicity, tolerability, PK/PD, immunogenicity, biomarkers, and antitumor activity of HB0045. The phase I study will enroll up to 54 subjects with advanced solid tumors who have progressed on or after standard of care therapy and for whom there is no further treatment available that in the judgement of the patient's physician would be beneficial. One cycle is defined as 21 days.
Timeline
- Start
- 2023-07-18
- Primary completion
- 2025-09-19
- Completion
- 2026-03-19
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HB0045 | Monoclonal antibody | 1.5 mg/kg | Intravenous |
| Subject | HB0045 | Monoclonal antibody | 5 mg/kg | Intravenous |
| Subject | HB0045 | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | HB0045 | Monoclonal antibody | 30 mg/kg | Intravenous |
| Subject | HB0045 | Monoclonal antibody | 40 mg/kg | Intravenous |