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

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/

Trial Details

NCT ID
NCT07007559
Phase
PHASE2
Sponsor
ALX Oncology Inc.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Evorpacept (ALX148)
  • Trastuzumab
  • Paclitaxel
  • Capecitabine
  • Eribulin
  • Gemcitabine
Locations (sample)
  • Tucson, Arizona, United States|32.22174,-110.92648
  • Duarte, California, United States|34.13945,-117.97729
  • Denver, Colorado, United States|39.73915,-104.9847
  • Golden, Colorado, United States|39.75554,-105.2211
  • Grand Junction, Colorado, United States|39.06387,-108.55065

Key Eligibility Criteria

  • Histologically confirmed invasive HER2+ breast cancer.
  • Received at least one prior line of therapy including T-DXd (ENHERTU) for locally advanced/metastatic HER2+ breast cancer. Prior neoadjuvant therap…
  • Progressed on or following the most recent line of therapy.
  • Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine).

For full eligibility, visit ClinicalTrials.gov.

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