drugset / Trial / NCT07007559
ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
NaSingle-groupOpen-labelTreatment
Summary
The Substudy Protocol ASPEN-09-03 is a Phase 2, single-arm, multicenter study evaluating the efficacy, safety, and tolerability of evorpacept in combination with trastuzumab and chemotherapy in participants with HER2-positive metastatic breast cancer who have previously received trastuzumab-deruxtecan. This substudy is actively recruiting. ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows: * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open. * Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.
Timeline
- Start
- 2025-12-10
- Primary completion
- 2027-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Evorpacept | Protein / enzyme biologic | — | Intravenous |
| Background | Capecitabine | Small molecule | — | Oral |
| Background | Eribulin | Small molecule | — | Intravenous |
| Background | Gemcitabine | Small molecule | — | Intravenous |
| Background | Paclitaxel | Small molecule | — | Intravenous |
| Background | Trastuzumab | Monoclonal antibody | — | Intravenous |
| Background | Vinorelbine | Small molecule | — | Intravenous |