RecruitingPhase 2

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

CA

CO

DC

FL

IL

MI

MN

MO

MT

NC

NE

NY

OH

OR

TX

VA

WA