drugset / Trial / NCT07086768
Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined Therapy in Patients With Advanced or Metastatic Solid Tumors
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a study that will enroll patients with cancer who have tumors that may have spread. The patients will know what medication they are being given. There will be 2 parts to the study. For the first part of the study only one medication will be taken, and the dose changed to a higher dose over time. In the second part of the study tow medications will be taken and the dose of the medication may be changed to a higher dose.
Timeline
- Start
- 2026-01-26
- Primary completion
- 2027-08-07
- Completion
- 2028-08-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BSI-082 | Unknown | 0.3 mg/kg | Intravenous |
| Subject | BSI-082 | Unknown | 1 mg/kg | Intravenous |
| Subject | BSI-082 | Unknown | 3 mg/kg | Intravenous |
| Subject | BSI-082 | Unknown | 10 mg/kg | Intravenous |
| Subject | BSI-082 | Unknown | 20 mg/kg | Intravenous |
| Background | Trastuzumab deruxtecan | Monoclonal antibody | — | — |