ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Recruiting · NCT07007559 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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. ASPEN-09-03 is a substudy under Master Protocol ASPEN-09, and additional substudies are as follows: * Metastatic colorectal cancer (CRC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open. * Recurrent/metastatic head and neck cancer (HNSCC) - dose escalation phase to evaluate evorpacept in combination with other drugs. This substudy is not open.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Histologically confirmed invasive HER2+ breast cancer based on an evaluable tumor tissue biopsy obtained after cessation of T-DXd (ENHERTU) treatment and no more than 6 months prior to C1D1.
- Received no more than 4 prior lines of HER2-directed therapy including at least one prior line of 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.
Exclusion criteria
- Untreated CNS metastases.
- 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 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.
Where it is running
54 locations listed across 17 US states.
- The University of Arizona Cancer Center - North Campus - Tucson, Arizona, United States
- City of Hope - Duarte, California, United States
- UC San Diego Moores Cancer Center - La Jolla, California, United States
- UC Irvine Health - Chao Family Comprehensive Cancer Center - Orange, California, United States
- Saint Joseph Hospital - Cancer Centers of Colorado - Denver, Colorado, United States
- Lutheran Hospital - Cancer Centers of Colorado - Golden, Colorado, United States
- Saint Mary's Regional Hospital - Cancer Centers of Colorado - Grand Junction, Colorado, United States
- The George Washington Medical facility Associates - Washington D.C., District of Columbia, United States
- Sylvester Comprehensive Cancer Center - Miami, Florida, United States
- City of Hope Chicago - Zion, Illinois, United States
- University of Michigan Rogel Cancer Center - Ann Arbor, Michigan, United States
- HealthPartners Frauenshuh Cancer Center - Saint Louis Park, Minnesota, United States
- Washington University School of Medicine- Siteman Cancer Center - St Louis, Missouri, United States
- St. Vincent Regional Hospital - Cancer Centers of Montana - Billings, Montana, United States
- Oncology Hematology West, Pc Dba Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Gabrail Cancer Center - Canton, Ohio, United States
- Oregon Health and Science University - Portland, Oregon, United States
- University of Texas Southwestern Medical Center - Dallas, Texas, United States
- Houston Methodist Cancer Center - Houston, Texas, United States
- The University of Texas M.D. Anderson Cancer Center - Houston, Texas, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- ASST Papa Giovanni XXIII - Bergamo, Italy
- CHU de Besancon - Besançon, France
- IRCCS Azienda Ospedaliero- Universitaria di Bologna, Policlinico di Sant'Orsola - Bologna, Italy
- Inha University Hospital - Incheon, South Korea
- Hospital Beata Maria Ana - Madrid, Spain
- IRCCS- Istituto Europeo di Oncologia - Milan, Italy
- Fondazione IRCCS San Gerardo Dei Tintori - Monza, Italy
- Nottingham University Hospital NHS Trust - Nottingham, United Kingdom
- Azienda Ospedaliero- Universitaria Maggiore della CaritÃ, SCDU Oncologia - Novara, Italy
- Hopital de l'Institut Curie - Paris, France
- Hopital Europeen Georges Pompidou (HEGP) - Paris, France
- Centre Hospitalier Universitaire (CHU) de Poitiers - Poitiers, France
- Centre Eugene Marquis - Rennes, France
- Seoul National University Hospital - Seoul, South Korea
- Severance Hospital, Yonsei University Health System - Seoul, South Korea
- Asan Medical Center - Seoul, South Korea
- Samsung Medical Center - Seoul, South Korea
- Korea University Guro Hospital - Seoul, South Korea
- National Cancer Centre Singapore - Singapore, Singapore
- Curie Oncology - Farrer - Singapore, Singapore
- Azienda Ospedaliero Universitaria delle Marche - Torrette, AN, Italy
- Hospital Universitario Virgen de la Victoria - Málaga, Andalusia, Spain
- Hospital Universitario Virgen Macarena - Seville, Andalusia, Spain
- Hospital Universitario De Basurto - Bilbao, Basque Country, Spain
- Hospital Universitari Vall d'Hebron - Barcelona, Catalonia, Spain
- Hospital Universitari Arnau de Villanova - Lleida, Catalonia, Spain
- IRCCS Azienda Ospedaliera Metropolitana - Genova, GE, Italy
- Barts Health NHS Trust - St Bartholomew's Hospital - London, Greater London, United Kingdom
- University Health Network, Princess Margaret Cancer Centre - Toronto, Ontario, Canada
- Velindre Cancer Centre, Velindre University NHS Trust - Cardiff, Wales, United Kingdom