PET imaging with [68Ga]Ga-ABY-025 to visualize HER2-positive and HER2-low tumors during HER2 therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants who have HER2-positive solid cancers or HER2-positive or HER2-low breast cancer and are starting or receiving FDA-approved HER2-targeted therapy will receive a dose of ABY-025 followed by a tracer dose of [68Ga]Ga-ABY-025. A PET/CT scan will be performed the same day after tracer injection to image tumor HER2 expression, and participants will have a safety follow-up visit 2–7 days later. Eligible patients must have prior biopsy or validated liquid biopsy evidence of HER2 expression or amplification and measurable disease outside the liver. Standard-of-care disease evaluations by the treating physician will continue alongside the investigational imaging.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Makenna Brown
• Email: makenna.l.brown@vumc.org
• Phone: +1 (615)421-4370

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 68Ga-XHER2 PET/CT imaging to see HER2 in solid tumors

  A noninvasive PET/CT imaging test using 68Ga-XHER2 is being tried to see if it reflects HER2 levels in solid tumors.

  Recruiting The First Affiliated Hospital of Xiamen University · Xiamen, Fujian · NCT07885436

• IL-15–Enhanced NK Cell Therapy for Solid Tumors

  A first-in-human, early-phase study tests whether IL-15–enhanced engineered NK cells are safe and can show early signs of effect in adults with relapsed or metastatic solid tumors.

  Recruiting Early Phase 1 Genovn Therapeutics PTE. LTD. · Chongqing · NCT07621471

• LATTICE radiotherapy vs moderately dose-escalated palliative radiation for metastases

  This study tests whether LATTICE radiotherapy given in 5 fractions works better than a standard palliative dose for patients with metastatic cancer who have 1–2 sizable tumors.

  Recruiting Phase 2 Stanford University · Palo Alto, California · NCT07594431

• Trastuzumab plus serplulimab with chemotherapy for HER2-positive advanced biliary tract or urothelial cancer after prior therapy

  This study will test whether adding trastuzumab and serplulimab to chemotherapy helps people with HER2-positive unresectable or metastatic biliary tract cancer or urothelial carcinoma who have not responded to standard treatment.

  Recruiting Phase 2 China Medical University, China · Shenyang, Liaoning · NCT07506057

• Givastomig with nivolumab and chemotherapy for CLDN18.2-positive metastatic stomach or gastroesophageal junction cancer

  This study will see if adding givastomig to nivolumab plus standard chemotherapy helps adults with CLDN18.2- and PD-L1-positive metastatic stomach or gastroesophageal junction cancer live longer without their disease getting worse.

  Recruiting at 5 sites Phase 2 I-Mab Biopharma US Limited · Goodyear, Arizona and 5 other locations · NCT07432295

• Selective ERBB2 inhibitor CGT4255 for adults with ERBB2-altered advanced solid tumors

  This trial tests a targeted drug called CGT4255 in adults with advanced solid tumors that have ERBB2 (HER2) changes to see if it is safe and shows anti-tumor activity.

  Recruiting at 15 sites Phase 1 Cogent Biosciences, Inc. · Scottsdale, Arizona and 14 other locations · NCT07361562

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.