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A Study of Evorpacept (ALX148) in Patients with Metastatic HER2-Positive Breast Cancer
EU CTIS ID: 2025-522012-16-00
What this study is testing
To evaluate the overall response rate of evorpacept in combination with trastuzumab and single-agent chemotherapy in the sub-population of participants with metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC) who have HER2 copy number amplification in ctDNA at baseline (ctDNA+).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Master Protocol • Participants must have at least one measurable lesion as defined by RECIST v1.1.
- Substudy Protocol: • Progressed on or following the most recent line of therapy
- Substudy Protocol: • LVEF ≥50%
- Substudy Protocol: • Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine)
- Substudy Protocol: • Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation
- Substudy Protocol: • 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).
You likely can't join if
- Master Protocol: • Participants with known CNS metastases unless treated and stable prior to enrollment
- Master Protocol: • Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients).
- Master Protocol: • Has an active autoimmune disease that has required systemic treatment in past 2 years
- Substudy Protocol: • Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen
- Substudy Protocol: • Other primary malignancy within 2 years
- Substudy Protocol: • Any condition that would be contraindicated to receiving trastuzumab
See the full eligibility criteria
- Master Protocol • Participants must have at least one measurable lesion as defined by RECIST v1.1.
- Substudy Protocol: • Progressed on or following the most recent line of therapy
- Substudy Protocol: • LVEF ≥50%
- Substudy Protocol: • Eligible to receive one of the following chemotherapy options (capecitabine, eribulin, gemcitabine, paclitaxel or vinorelbine)
- Substudy Protocol: • Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockroft-Gault equation
- Substudy Protocol: • 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).
- Master Protocol • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.
- Master Protocol • Life expectancy of at least 3 months
- Master Protocol • 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
- Substudy Protocol: • Histologically confirmed invasive HER2 positive breast cancer
- Substudy Protocol: • 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.
- Master Protocol: • Participants with known CNS metastases unless treated and stable prior to enrollment
- Master Protocol: • Intolerance to or who have had a severe allergic or anaphylactic reaction to antibodies or infused therapeutic proteins or participants who have had a severe allergic or anaphylactic reaction to any of the substances included in the study drug (including excipients).
- Master Protocol: • Has an active autoimmune disease that has required systemic treatment in past 2 years
- Substudy Protocol: • Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen
- Substudy Protocol: • Other primary malignancy within 2 years
- Substudy Protocol: • Any condition that would be contraindicated to receiving trastuzumab
- Master Protocol: • Following anti-cancer therapy with insufficient washout : 1. chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days 2. Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days
- Master Protocol: • Prior exposure to any anti-CD47 or anti-SIRPα agent.
- Master Protocol: • History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.
- Master Protocol: • Had an allogeneic tissue/solid organ transplant.
- Master Protocol: • Any active, unstable cardiovascular disease
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Singapore
- United States
- United Kingdom
- Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Singapore; United States; United Kingdom; Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.