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RecruitingEarly Phase 1

Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy

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

  • Procedures mentioned: CT scans, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study drug will be administered and \[68Ga\]Ga-ABY-025 PET/CT scan will be obtained the same day after injection of study drug."
  • "Patients will have a follow visit 2-7 days post injection of the study drug."
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 whether a radioactive tracer called [68Ga]Ga-ABY-025 can help PET scans find and show tumors more clearly. It is for adults with advanced cancer who are starting or have recently started standard treatment that targets HER2, a protein found in some cancers.

The purpose of this study is to determine if the radiotracer, \[68Ga\]Ga-ABY-025, used for PET imaging can help us better identify and visualize lesions or tumors, in patients who are receiving standard of care therapy HER2+ cancers.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • Your cancer has spread nearby and cannot be removed by surgery, or it has spread to other parts of your body.
  • Your doctor says you qualify for standard HER2-targeted treatment for an FDA-approved use.
  • You plan to start HER2-targeted treatment, or you have started and received no more than 6 treatment cycles.
  • Past tissue testing showed HER2-positive cancer, or HER2-low breast cancer. A standard blood biopsy showing extra copies of the HER2 gene also qualifies.
  • Scans show cancer that can be measured, including at least one area outside your liver.
  • You are expected to live at least 6 months.
  • You may join if your cancer has spread to your brain.

Who can't join

  • The only cancer that can be measured is in your liver.
  • You cannot follow the study procedures.
  • You are allergic or very sensitive to any part of [68Ga]Ga-ABY-025.
  • You are pregnant or breastfeeding.
  • Your cancer is HER2-negative and has no FDA-approved use for HER2-targeted treatment.
  • You cannot lie flat for 30 minutes during a scan.
  • Your doctor thinks another medical or mental health condition would keep you from taking part successfully.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age ≥ 18 years. 2. Patients with unresectable locally advanced or metastatic cancer who are eligible for standard of care treatment with HER2-targeted therapy per the discretion of their treating physician for an FDA-approved indication. Patients who are planning to start HER2-targeted therapy at the time of study enrollment. Patients who have recently begun HER2 treatment and have received no more than 6 cycles will be eligible for enrollment. 3. Must have a previous biopsy demonstrating HER2 expression in at least one lesion (HER2+ solid cancer, or breast cancer patients who are HER2+ or HER2-low) as defined by IHC and FISH studies or with HER2 amplification as defined by a liquid biopsy that was done as standard of care testing for the patient's cancer type. 4. Measurable disease on CT, FDG-PET, or MRI imaging for RECIST evaluation; patient must have measurable disease outside the liver. 5. Life expectancy of at least 6 months. Patients with brain metastases are permitted to enroll in this study. Exclusion Criteria: 1. Measurable sites of disease only in the liver. 2. Inability to comply with study procedures. 3. Hypersensitivity or allergy to any component of \[68Ga\]Ga-ABY-025. 4. Pregnant or breastfeeding. 5. HER2-negative cancers that have no FDA approved indication for treatment with HER2-directed therapy. 6. Inability to lie flat for 30 minutes during an imaging session. 7. Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.

Study sites (1)

TN