Phase 2 Study of Evorpacept with Trastuzumab and Chemotherapy for Adults with Metastatic HER2-Positive Breast Cancer Previously Treated with Trastuzumab-Deruxtecan

What this Trial Is About

Researchers are evaluating the combination of evorpacept with trastuzumab and chemotherapy in adults with HER2-positive metastatic breast cancer who have previously been treated with trastuzumab-deruxtecan. This Phase 2, single-arm, multicenter study aims to assess the treatments effectiveness, safety, and tolerability. It is part of a larger master protocol studying evorpacept with various anti-cancer therapies in advanced malignancies. Participants will receive evorpacept and trastuzumab intravenously every three weeks, along with one of several chemotherapy options chosen by their doctor. Chemotherapy options include oral capecitabine twice daily for 14 days every three weeks or intravenous eribulin, gemcitabine, paclitaxel, or vinorelbine with varying schedules. Treatment continues until disease progression, unacceptable side effects, participant choice, investigator decision, or study end. During the study, participants will have assessments of tumor response using standard criteria approximately six months after enrollment ends. Researchers will monitor overall response rate, clinical benefit rate, duration of response, progression-free survival, overall survival, and side effects. Blood samples will be collected to study drug levels and immune response. Participants are followed until 28 days after the last treatment dose, with safety and efficacy carefully tracked throughout the study period.

ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer