Protocol 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, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
ALX Oncology Inc.
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.
Description
Participants will continue study treatment until disease progression, death, unacceptable toxicity, participant request to stop treatment, investigator decision or study termination by the sponsor. As ASPEN-09-03 (MBC) is the only substudy open under ASPEN-09, the information reflected in the enrollment number, arms/interventions, outcome measures, and eligibility criteria currently includes only MBC.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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 therapy which resulted in relapse within 6 months of completion of T-DXd will be considered a line of treatment for metastatic disease. Participants who discontinue T-DXd due to intolerance are considered eligible. * Progressed on or following the most recent line of therapy. * Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine,…
Interventions
- DrugEvorpacept (ALX148)
IV infusion
- DrugTrastuzumab
IV infusion
- DrugPaclitaxel
IV infusion
- DrugCapecitabine
Oral administration
- DrugEribulin
IV infusion
- DrugGemcitabine
IV infusion
- DrugVinorelbine
IV infusion
Locations (32)
- The University of Arizona Cancer Center - North CampusTucson, Arizona
- City of HopeDuarte, California
- Saint Joseph Hospital - Cancer Centers of ColoradoDenver, Colorado
- Lutheran Hospital - Cancer Centers of ColoradoGolden, Colorado
- Saint Mary's Regional Hospital - Cancer Centers of ColoradoGrand Junction, Colorado
- The George Washington Medical facility AssociatesWashington D.C., District of Columbia