ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination with Trastuzumab and Chemotherapy in Participants with Metastatic HER2-Positive Breast Cancer (ASPEN-09-03)
Study Sponsor: ALX Oncology Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: Phase II
Purpose of study: The purpose of this research is to assess the response, safety and tolerability of the investigational drug evorpacept in combination with trastuzumab and a chemotherapy drug that your doctor has chosen for your HER2+ metastatic breast cancer (MBC) that has come back or grown despite prior treatment with a HER2 directed therapy. Evorpacept works by helping your immune system to target and destroy cancer cells.
Inclusion Criteria
– Must be at least 18 years or older at time of consent.
– Must have at least one measurable lesion per RECIST 1.1.
– Must have an ECOG status of 0-1.
– Have life expectancy of at least 3 months per the opinion of the physician.
– Side effects from previous treatments/therapies must have returned to baseline.
– Have HER2 positive breast cancer
– Received at least 1 prior treatment that included T-DXd (Trastuzumab Deruxtecan)
– Must be able to receive one of the following chemo options: capecitabine, eribulin, gemcitabine, paclitaxel, or vinorelbine.
– Adequate organ function as determined by local lab tests.
– Must be able to provide available tumor tissue.
*Additional inclusion criteria may apply, and can be discussed with the treating physician and research team.
Exclusion Criteria:
– Has untreated or unstable CNS metastasis (unless treated and stable at time of consent).
– Has had chemotherapy, hormonal therapy, or radiation therapy within 14 days, OR has had immune therapy within 28 days.
– Has had a solid organ transplant.
– Has had an allergic reaction to antibodies or infused proteins.
– Has an active, unstable cardiac disease.
– Has had other primary cancer (other than HER2 positive breast) within the last 2 years.
*Additional exclusion criteria may apply, and can be discussed with the treating physician and research team.
Study Contact:
Alissa Gavenda
(952) 993-6705
alissa.gavenda@healthpartners.com
