drugset / Trial / NCT05091528
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2). Participants will be enrolled into each Arm based on cancer diagnosis and prior therapies.
Timeline
- Start
- 2022-02-08
- Primary completion
- 2022-07-07
- Completion
- 2022-07-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1000 mg/m2 | Oral |
| Subject | PERTUZUMAB ZUVOTOLIMOD | Unknown | 0.45 mg/kg | Subcutaneous |
| Subject | PERTUZUMAB ZUVOTOLIMOD | Unknown | 0.6 mg/kg | Subcutaneous |
| Subject | Trastuzumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 5.4 mg/kg | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | 6.4 mg/kg | Intravenous |
| Subject | Tucatinib | Small molecule | 300 mg | Oral |