Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 25, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07007559). This is a study registration, not published results. Lead sponsor: ALX Oncology Inc.. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Breast Cancer, Metastatic. Interventions: DRUG: Evorpacept (ALX148); DRUG: Trastuzumab; DRUG: Paclitaxel; DRUG: Capecitabine; DRUG: Eribulin; DRUG: Gemcitabine; DRUG: Vinorelbine. Primary outcome measures: Overall Response Rate (ORR) using RECIST v1.1 based on BICR assessment , Approximately 6 months after the last participant is enrolled. Brief 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.