ASPEN-09-03: A Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Metastatic HER2-Positive Breast Cancer
Protocol ASPEN-09-03: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination With Trastuzumab and Chemotherapy in Participants With Metastatic HER2-Positive Breast Cancer, a Substudy Under Master Protocol ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests evorpacept with trastuzumab and chemotherapy for HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein that helps cancer grow. The study is enrolling people who have already received trastuzumab-deruxtecan (T-DXd, or ENHERTU) to learn how well this treatment works and how safe it is.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- A tumor sample must confirm HER2-positive breast cancer. The sample must be taken after stopping T-DXd and within 6 months before study treatment starts.
- Have had no more than 4 rounds of different HER2-targeted treatments for advanced or spreading cancer, including T-DXd. People who stopped T-DXd because of side effects may qualify. Treatment before surgery counts if cancer returned within 6 months after finishing T-DXd.
- Cancer must have grown or spread during or after the most recent treatment and must be measurable on scans.
- Must be able to receive capecitabine, eribulin, gemcitabine, paclitaxel, or vinorelbine chemotherapy.
- The heart must pump out at least 50% of its blood with each beat.
- Must be fully active or able to do light work, and expected to live at least 3 months.
- Kidney and liver blood tests must meet study limits.
- Side effects from past treatment or surgery must be back to their earlier level or mild. Lasting side effects may be allowed if the study doctor finds they are not a safety risk.
Who can't join
- Untreated cancer spread to the brain or spinal cord, or another separate cancer within the past 2 years.
- Past treatment with drugs that target CD47 or SIRPα, or a condition that makes trastuzumab unsafe.
- Complete lack of DPD, a protein that breaks down certain chemotherapy drugs, or serious side effects from past fluorouracil (5-FU) treatment.
- Not enough time since past cancer treatment. The usual wait is 14 days for chemotherapy, hormone therapy, radiation, or small-molecule drugs, and 28 days for immune or other biologic treatments. A shorter wait may apply based on how fast the drug leaves the body.
- Past immune attacks on red blood cells or platelets, or a blood transfusion reaction that destroyed red blood cells.
- A tissue or solid organ transplant from a donor, or active, unstable heart or blood vessel disease.
- Unable to tolerate antibody medicines or infused treatment proteins, or a severe allergic reaction to them or any study drug ingredient.
- An active disease in which the immune system attacks the body that needed treatment affecting the whole body in the past 2 years.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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: 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.
Study sites (28)
AZ
- Mayo Clinic Building-Phoenix · Phoenix, AZ 85054More trials in Phoenix
- The University of Arizona Cancer Center - North Campus · Tucson, AZ 85719More trials in Tucson
CA
- City of Hope · Duarte, CA 91010More trials in Duarte
- UC San Diego Moores Cancer Center · La Jolla, CA 92037More trials in La Jolla
- UC Irvine Health - Chao Family Comprehensive Cancer Center · Orange, CA 928686More trials in Orange
CO
- Saint Joseph Hospital - Cancer Centers of Colorado · Denver, CO 80218More trials in Denver
- Lutheran Hospital - Cancer Centers of Colorado · Golden, CO 80401More trials in Golden
- Saint Mary's Regional Hospital - Cancer Centers of Colorado · Grand Junction, CO 81501More trials in Grand Junction
DC
- The George Washington Medical facility Associates · Washington D.C., DC 20037More trials in Washington D.C.
FL
- Mayo Clinic · Jacksonville, FL 32224More trials in Jacksonville
- Sylvester Comprehensive Cancer Center · Miami, FL 33136More trials in Miami
- Moffitt Cancer Center · Tampa, FL 33612More trials in Tampa
IL
- City of Hope Chicago · Zion, IL 60099More trials in Zion
MI
- University of Michigan Rogel Cancer Center · Ann Arbor, MI 48109More trials in Ann Arbor
MN
- Mayo Clinic Cancer Center · Rochester, MN 55905More trials in Rochester
- HealthPartners Frauenshuh Cancer Center · Saint Louis Park, MN 55426Study Coordinator · Study contactMore trials in Saint Louis Park
MO
- Washington University School of Medicine- Siteman Cancer Center · St Louis, MO 63108More trials in St Louis
MT
- St. Vincent Regional Hospital - Cancer Centers of Montana · Billings, MT 59102More trials in Billings
NC
- Duke Cancer Institute · Durham, NC 27710More trials in Durham
NE
- Oncology Hematology West, Pc Dba Nebraska Cancer Specialists · Omaha, NE 68130Study Coordinator · Study contact · 402-334-4773More trials in Omaha
NY
- Memorial Sloan Kettering Cancer Center · New York, NY 10022More trials in New York
OH
- Gabrail Cancer Center · Canton, OH 44718Study Coordinator · Study contactMore trials in Canton
OR
- Oregon Health and Science University · Portland, OR 97239More trials in Portland
TX
- University of Texas Southwestern Medical Center · Dallas, TX 75390More trials in Dallas
- Houston Methodist Cancer Center · Houston, TX 77030More trials in Houston
- The University of Texas M.D. Anderson Cancer Center · Houston, TX 77030More trials in Houston
VA
- Virginia Cancer Specialists · Fairfax, VA 22031More trials in Fairfax
WA
- Fred Hutchinson Cancer Center · Seattle, WA 98109More trials in Seattle