A Phase 1b/2 Multi Arm Study Evorpacept combination with Therapies Advanced Malignancies (APEN-09)
Research type
Research Study
Full title
Master protocol: A Phase 1b / 2, Multicenter, Multi Arm Study of Evorpacept in Combination with Anti-cancer Therapies in Advanced / Metastatic Malignancies (ASPEN-09). Substudy: 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)
IRAS ID
1012669
Contact name
Mary Liu
Contact email
Sponsor organisation
ALX Oncology
Clinicaltrials.gov Identifier
Research summary
The ASPEN-09-03 substudy is a mid-stage (Phase 2) clinical trial taking place at multiple locations. It’s testing how well medication called evorpacept, when combined with trastuzumab and a chemotherapy, works for patients with HER2-positive metastatic breast cancer. Patients in the study must have already been treated with another medication called Trastuzumab-Deruxtecan (Enhertu), but their cancer has worsened.
Everyone in the study will receive the combination of evorpacept, trastuzumab, and a chemotherapy. A special group called a Safety Review Committee (SRC) - made up of doctors and members of the study sponsor team - will regularly check the safety of the treatment throughout the trial. They’ll look at safety results for each type of chemotherapy being tested.
Before starting treatment, participants will go through a screening process lasting up to 28 days (with imaging done within 7 days). They will continue the treatment until one of the following happens: The cancer worsens (based on a formal review), The participant chooses to stop, Side effects become too severe, or the study medication or consent is withdrawn, or the sponsor ends the study.
Scans to check the tumour will be done before starting treatment and about every 6 weeks during treatment.
After stopping treatment, there will be a follow-up visit 4 weeks later to check for side effects. After that, the study team will check in every 3 months for up to 2 years to see how the participant is doing. If someone can’t be contacted by phone, the study may use other approved ways to find out if they’re still alive.REC name
South West - Central Bristol Research Ethics Committee
REC reference
25/SW/0135
Date of REC Opinion
9 Dec 2025
REC opinion
Further Information Favourable Opinion