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

New imaging tracer to track HER2-targeted therapy effectiveness

NCT: NCT06828588 · Status: NOT YET RECRUITING · Phase: Phase 1 · Sponsor: Vanderbilt-Ingram Cancer Center · Started: 2026-02 · Est. Completion: 2029-12

Plain English Summary

Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy is a Phase 1 clinical trial sponsored by Vanderbilt-Ingram Cancer Center studying Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER 2 Low-expressing Breast Cancer. This study tests a new imaging agent called [68Ga]Ga-ABY-025 to see if it can better visualize tumors in patients receiving HER2-targeted cancer treatment. It is for patients with advanced or metastatic HER2-positive or HER2-low cancers who are starting or have recently started HER2-targeted therapy. Participation involves receiving an injection of the imaging tracer and undergoing a PET/CT scan. Alternatives include standard imaging methods like CT, PET, or MRI, which may not always clearly show tumor activity or response to treatment. The trial aims to enroll 30 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced or metastatic cancer that has shown HER2 expression. Patients who are starting or have received no more than 6 cycles of HER2-targeted therapy. Individuals with measurable disease outside the liver and a life expectancy of at least 6 months. Cannot join if cancer is only in the liver, if allergic to the tracer, pregnant/breastfeeding, or unable to lie still for 30 minutes. This trial is studying Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER 2 Low-expressing Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures the safety of the new imaging tracer by monitoring for any side effects after injection and scanning, ensuring it is safe for patients. The specific primary outcome measures are: Determine safety of [68Ga]Ga-ABY-025 PET by assessing for adverse events following the injection and PET imaging. (up to 21± 14 days from second administration of [68Ga]Ga-ABY-025. Assessments will be performed as part of the routine standard of care for patients undergoing HER2-targeted anti-cancer treatment.). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.

Why This Trial Matters

This trial matters because it aims to improve the ability to see and track tumors in patients receiving HER2-targeted therapies, potentially leading to more personalized and effective treatment strate This research targets Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER 2 Low-expressing Breast Cancer, where improved treatment options are needed.

Investor Insight

This pilot study signals early-stage research into novel diagnostic tools for a significant cancer market, with potential to enhance existing HER2-targeted therapies and improve patient outcomes. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this imaging tracer could provide more information about your tumor's response to treatment compared to standard scans. Be prepared for an injection of the tracer and a PET/CT scan, which will take a few hours. You will be monitored for any side effects for about three weeks after the scan. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Full 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.

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06828588?

NCT06828588 is a Phase 1 INTERVENTIONAL study titled "Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy." It is currently not yet recruiting and is sponsored by Vanderbilt-Ingram Cancer Center. The trial targets enrollment of 30 participants.

What conditions does NCT06828588 study?

This trial investigates treatments for Locally Advanced Cancer, Metastatic Cancer, HER2, HER2 + Breast Cancer, HER2 + Gastric Cancer, Squamous Cell Carcinoma of Head and Neck, Esophageal Squamous Cell Carcinoma, HER 2 Low-expressing Breast Cancer. The primary condition under study is Locally Advanced Cancer.

What treatments are being tested in NCT06828588?

The interventions being studied include: [68Ga]Ga-ABY-025 (DRUG). Subjects receive a tracer dose of \[68Ga\]Ga-ABY-025 and will receive a PET/CT scan a few hours after the injection.

What does Phase 1 mean for NCT06828588?

Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.

What is the current status of NCT06828588?

This trial is currently "Not Yet Recruiting." It started on 2026-02. The estimated completion date is 2029-12.

Who is sponsoring NCT06828588?

NCT06828588 is sponsored by Vanderbilt-Ingram Cancer Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06828588?

The trial aims to enroll 30 participants. The trial has not yet started recruiting.

How is NCT06828588 designed?

This is a interventional study, uses na allocation, follows a single_group design, employs none masking.

What are the primary outcomes being measured in NCT06828588?

The primary outcome measures are: Determine safety of [68Ga]Ga-ABY-025 PET by assessing for adverse events following the injection and PET imaging. (up to 21± 14 days from second administration of [68Ga]Ga-ABY-025. Assessments will be performed as part of the routine standard of care for patients undergoing HER2-targeted anti-cancer treatment.). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06828588 being conducted?

This trial is being conducted at 1 site, including Nashville, Tennessee (United States).

Where can I find official information about NCT06828588?

The official record for NCT06828588 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06828588. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06828588 testing in simple terms?

This study tests a new imaging agent called [68Ga]Ga-ABY-025 to see if it can better visualize tumors in patients receiving HER2-targeted cancer treatment. It is for patients with advanced or metastatic HER2-positive or HER2-low cancers who are starting or have recently started HER2-targeted therapy.

Why is this trial significant?

This trial matters because it aims to improve the ability to see and track tumors in patients receiving HER2-targeted therapies, potentially leading to more personalized and effective treatment strate

What are the potential risks of participating in NCT06828588?

The main risk is an allergic reaction to the imaging tracer, though this is uncommon. Potential side effects are generally mild and may include injection site reactions or temporary discomfort. As with any medical procedure, there is a small risk associated with radiation exposure from the tracer. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06828588?

Ask your doctor if this imaging tracer could provide more information about your tumor's response to treatment compared to standard scans. Be prepared for an injection of the tracer and a PET/CT scan, which will take a few hours. You will be monitored for any side effects for about three weeks after the scan. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06828588 signal from an investment perspective?

This pilot study signals early-stage research into novel diagnostic tools for a significant cancer market, with potential to enhance existing HER2-targeted therapies and improve patient outcomes. This is a Phase 1 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participation involves receiving an injection of the imaging tracer and undergoing a PET/CT scan. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.