ASPEN-09-03 - A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: II

Linee di trattamento: Seconda linea, Terza/N linea

Criteri di inclusione: 

- 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, 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 safety risk by Investigator judgment.

Criteri di esclusione: 

- 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:
   1. 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.
   2. 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 included in the study drug (including excipients).
- Has an active autoimmune disease that has required systemic treatment in past 2 years.
- Other primary malignancy within 2 years.

Trattamento sperimentale: 

Evorpacept+Trastuzumab+Chemo in participants with metastatic HER2+ breast cancer

Trattamento di controllo: 

 - 

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2025-522012-16-00 - NCT07007559

Data di inserimento: 08.07.2026

Promotore

ALX Oncology Inc.

Principal Investigator ITALIA

Riferimento: Dr. - -

Telefono: 00000

Email: na@na.it

Localita: -