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New treatment option for Breast Cancer, Metastatic
Official title ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
ClinicalTrials.gov ID: NCT07007559
What this study is testing
What is Evorpacept (ALX148)?
Evorpacept (ALX148) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer, metastatic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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).
- Measurable disease as defined by RECIST v1.1.
You likely can't join if
- Participants with known CNS metastases unless treated and stable prior to enrollment.
- Prior exposure to any anti-CD47 or anti-SIRPα agent.
- Any condition that would be contraindicated to receiving trastuzumab
- Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen
- Following anti-cancer therapy with insufficient washout before start of treatment:
- chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of...
See the full 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 therapy which resulted in relapse within 6 months of completion of T-DXd will...
- 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).
- Measurable disease as defined by RECIST v1.1.
- LVEF ≥50%.
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 to 1.
- Life expectancy of at least 3 months.
- Adequate renal function (estimated creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) 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).
- 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 and which do not constitute a...
- Participants with known CNS metastases unless treated and stable prior to enrollment.
- Prior exposure to any anti-CD47 or anti-SIRPα agent.
- Any condition that would be contraindicated to receiving trastuzumab
- Has a diagnosis of complete dihydropyrimidine dehydrogenase (DPD) deficiency or significant toxicity with prior flurouracil (5FU) based regimen
- Following anti-cancer therapy with insufficient washout before start of treatment:
- chemotherapy, hormonal therapy, radiation therapy or small molecule anti-cancer therapy within 14 days or 5 half-lives (whichever is shorter) of start of treatment.
- Immune therapy or other biologic therapy (e.g., monoclonal antibodies, antibody-drug conjugates) for the treatment of cancer for: 28 days or 5 half-lives (whichever is shorter) of start of treatment).
- History of autoimmune hemolytic anemia, autoimmune thrombocytopenia, or hemolytic transfusion reaction.
- Had an allogeneic tissue/solid organ transplant.
- Any active, unstable cardiovascular disease.
- 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...
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Other primary malignancy within 2 years.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Duarte, California, United States
- La Jolla, California, United States
- Orange, California, United States
- Denver, Colorado, United States
- Golden, Colorado, United States
- Grand Junction, Colorado, United States
- Washington D.C., District of Columbia, United States
- Miami, Florida, United States
- Zion, Illinois, United States
- Ann Arbor, Michigan, United States
- Saint Louis Park, Minnesota, United States
- Billings, Montana, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Canton, Ohio, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
- Seattle, Washington, United States
+ 17 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Duarte, California, United States; La Jolla, California, United States; Orange, California, United States; Denver, Colorado, United States; Golden, Colorado, United States and 31 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.