ASPEN-09: A Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
- Trial number:
- NCT07007559
- Trial phase:
- 2
- Study type:
- Chemotherapy, Immunotherapy, Targeted therapy
- Overall status:
- Recruiting
Study start date
Scientific title
Summary
(all substudies):
* Participants must have at least one measurable lesion as defined by RECIST v1.1.* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1. * Life expectancy of at least 3 months * Participants must have recovered from all AEs due to previous therapies, procedures, and surgeries to baseline severity or ≤Grade 1 per NCI CTCAE v5.0 except for AEs not deemed reversible which do not constitute a safety risk by Investigator judgment
MBC substudy:
* Histologically confirmed invasive HER2 positive breast cancer* Available tumor tissue (FFPE slides or block). A fresh biopsy is preferred but optional. * Received at least one prior line of therapy including T-DXd for locally advanced/metastatic HER2 positive 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. * 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) * LVEF ≥50% * Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation * Adequate liver function: * Total bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if the participant has documented Gilbert syndrome); * Aspartate and alanine transaminase (AST and ALT) ≤3 x ULN (≤5.0 x ULN if liver involved by metastatic disease).