[68Ga]Ga-ABY-025 Imaging for Cancer

Overseen By Nicole Jones

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Vanderbilt-Ingram Cancer Center

Must be taking: HER2-targeted therapy

Disqualifiers: Liver-only disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special imaging drug, [68Ga]Ga-ABY-025, can enhance doctors' ability to see tumors in patients undergoing treatment for HER2+ cancers. It provides a clearer picture of the body's internal state, potentially aiding in more effective cancer management and treatment. Individuals with HER2+ cancers who are beginning or have recently begun treatment and have measurable tumors, excluding those in the liver, may be suitable candidates for this trial. As an Early Phase 1 trial, this research focuses on understanding the imaging drug's effects in people, offering participants an opportunity to contribute to groundbreaking advancements in cancer treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that patients can be actively undergoing or planning to start HER2-targeted therapy, so it seems you may continue with your current treatment.

What prior data suggests that this radiotracer is safe for PET imaging?

Research has shown that [68Ga]Ga-ABY-025, a special substance used in PET scans, has been tested in earlier studies on patients with advanced breast cancer. These studies found that the treatment is generally well-tolerated, meaning most people did not experience serious side effects. This suggests that the treatment is safe for humans based on current information. However, since this study remains in an early stage, monitoring for any possible side effects is crucial. Participants will be closely observed for any reactions after receiving the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about [68Ga]Ga-ABY-025 because it offers a new way to visualize cancer activity in patients receiving HER2-targeted therapy. Unlike traditional imaging methods, this treatment uses a radiolabeled affibody to provide more detailed PET/CT images of HER2 expression in tumors. This could help doctors make more informed decisions about continuing or changing a patient’s treatment plan by showing how well the cancer is responding to therapy. Additionally, by targeting HER2, it may offer more personalized insights into the effectiveness of HER2-targeted treatments, potentially improving outcomes for patients.

What evidence suggests that [68Ga]Ga-ABY-025 imaging is effective for identifying and visualizing tumors in HER2+ cancer patients?

Research shows that the radiotracer [68Ga]Ga-ABY-025, used in PET scans, holds promise for spotting and visualizing tumors in patients with HER2-positive cancers. In a study with patients who had metastatic breast cancer, this imaging method clearly highlighted cancerous areas, providing important results. Another study with 50 women confirmed that [68Ga]Ga-ABY-025 PET scans effectively assessed HER2 levels, crucial for targeting treatments in these cancers. In this trial, participants will receive [68Ga]Ga-ABY-025 for PET/CT imaging to evaluate its effectiveness in assessing HER2 levels during and after HER2-targeted therapy. These early findings suggest that this method could be a valuable tool in evaluating and treating HER2-positive cancers. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for patients with HER2-positive cancers who are currently receiving standard of care therapy. Specific eligibility criteria were not provided, so it's important to contact the study organizers for detailed requirements.

Inclusion Criteria

My scans show cancer that can be measured, not just in my liver.

My doctor expects me to live at least 6 more months, even with brain metastases.

My cancer cannot be surgically removed and is advanced, but I can receive HER2 therapy.

Exclusion Criteria

Inability to comply with study procedures

Hypersensitivity or allergy to any component of [68Ga]Ga-ABY-025

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a dose of ABY-025 followed by a tracer dose of [68Ga]Ga-ABY-025, with PET/CT imaging performed on Day 0

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events and undergo follow-up visits at 24 hours and 21 days post-infusion

21 days

2 visits (in-person)

Long-term Follow-up

Repeat HER2 PET imaging at 12 months from study consent or at the time of treatment discontinuation

12 months

What Are the Treatments Tested in This Trial?

Interventions

• [68Ga]Ga-ABY-025

Trial Overview The study is testing a new radiotracer called [68Ga]Ga-ABY-025 in combination with an ABY-025 loading dose. The goal is to see if this tracer can improve PET scan imaging of tumors in patients undergoing HER2-targeted treatments.

How Is the Trial Designed?

Group I: Study Arm (ABY-025) Experimental Treatment 2 Interventions

This is a pilot study of \[68Ga\]Ga-ABY-025, a radiolabeled affibody, imaging in patients undergoing treatment with HER2-targeted therapy. The PET/CT imaging ("HER2 PET" imaging) will be performed at, prior to, or during the time a patient is receiving treatment with HER2-targeted therapy. A second HER2 PET will be collected at time of therapy treatment discontinuation or 12 months from study consent. Patients will be infused with the study drug, Ga-ABY-025, on Day 0, followed by PET/CT imaging post infusion. Participants will undergo follow-up visits to assess for adverse reactions at 24 hours and 21 days post infusion (± 7 days). Participants will undergo standard of care work-up for their malignancy as determined by their treatment team (e.g. biopsy, additional imaging, observation, treatment for metastatic disease). Either at 12 months after enrollment in the study or at the time of treatment discontinuation (whichever comes first), repeat HER2 PET imaging will

Who Is Running the Clinical Trial?

Vanderbilt-Ingram Cancer Center

Lead Sponsor

Trials

221

Recruited

64,400+

Published Research Related to This Trial

68Ga-based imaging agents significantly enhance the capabilities of positron emission tomography (PET) for improved diagnostics and personalized medicine.

The review highlights the importance of regulatory requirements in the production and application of 68Ga radiopharmaceuticals, which are crucial for both pre-clinical and clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

68Ga-Based radiopharmaceuticals: production and application relationship. Velikyan, I.[2022]

(68)Ga is a promising radionuclide for PET imaging that can be produced without a cyclotron, allowing for easier distribution of PET scans.

There is ongoing research into new (68)Ga-labeled radiopharmaceuticals, including amino acid and nitroimidazole derivatives, which may provide effective alternatives to current (18)F-labeled agents like FDG for tumor management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(68)Ga-labeled radiopharmaceuticals for positron emission tomography. Shetty, D., Lee, YS., Jeong, JM.[2021]

The use of 68Ga in imaging agents has significantly increased in oncology, but its application in imaging infections and inflammation remains underdeveloped despite high medical demand.

This review highlights potential pathways for creating 68Ga-based imaging agents that could improve diagnosis and treatment management for patients with infections and inflammatory diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective of 68Ga Radionuclide Contribution to the Development of Imaging Agents for Infection and Inflammation. Velikyan, I.[2019]

The developed freeze-dried BPAMD kit allows for the preparation of 68Ga-BPAMD with over 95% radiochemical purity, making it a reliable option for imaging bone lesions in patients.

Clinical studies demonstrated that 68Ga-BPAMD effectively accumulates in bone lesions of patients with metastatic bone cancer, indicating its potential for accurate PET scanning of skeletal metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Convenient Formulation of 68Ga-BPAMD Patient Dose Using Lyophilized BPAMD Kit and 68Ga Sourced from Different Commercial Generators for Imaging of Skeletal Metastases. Guleria, M., Das, T., Amirdhanayagam, J., et al.[2019]

The radiotracer [68Ga]Ga-DATA5m.SA.FAPi can be prepared easily at room temperature and shows high stability and affinity for FAP, making it a promising tool for imaging in cancer diagnostics.

In clinical trials with six prostate cancer patients, [68Ga]Ga-DATA5m.SA.FAPi demonstrated rapid and stable tumor uptake, supporting its potential as an effective diagnostic tool for FAP imaging in tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Translational assessment of a DATA-functionalized FAP inhibitor with facile 68Ga-labeling at room temperature. Escudero-Castellanos, A., Kurth, J., Imlimthan, S., et al.[2023]

In a study of 75 cancer patients, [68Ga]Ga-DOTA-FAPI-04 PET/CT demonstrated a significantly higher detection rate for primary tumors (98.2%) compared to [18F] FDG PET/CT (82.1%), indicating its superior diagnostic capability.

[68Ga]Ga-DOTA-FAPI-04 PET/CT also outperformed [18F] FDG PET/CT in detecting lymph node involvement and metastases, with sensitivity rates of 86.4% versus 45.5% for lymph nodes and 83.8% versus 59.5% for bone and visceral metastases, highlighting its effectiveness in identifying metastatic disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of [68Ga]Ga-DOTA-FAPI-04 and [18F] FDG PET/CT for the diagnosis of primary and metastatic lesions in patients with various types of cancer. Chen, H., Pang, Y., Wu, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6420710/

Diagnostic HER2-binding radiopharmaceutical, [68Ga]Ga- ... The phase I clinical study applying [68Ga]Ga-ABY-025 in 16 patients with metastatic breast cancer demonstrated clinically relevant results [8,12-14]. The ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.1035

[68Ga]Ga-ABY-025 PET in HER2-positive breast cancer Methods: [68Ga]Ga-ABY-025 PET and [18F]-FDG PET images from 50 women with biopsy confirmed HER2 positive breast cancer were examined. Each ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06828588

Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients ... 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 ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/early/2023/07/13/jnumed.122.265364

Human Epidermal Growth Factor Receptor 2–Targeting [ 68 ... [68Ga]Ga-ABY-025 PET/CT showed strong potential in evaluating HER2 expression in patients with metastatic breast cancer (MBC) in an early-phase ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4858610/

Good manufacturing practice production of [68Ga]Ga-ABY ... The combination of high peptide content radiopharmaceutical and whole-body imaging at 2 hours post injection appeared to be optimal for routine clinical use.

6. ejnmmipharmchem.springeropen.com ejnmmipharmchem.springeropen.com/articles/10.1186/s41181-023-00226-y

Optimized, automated and cGMP-compliant synthesis of the ... In a clinical trial (NCT01858116) [68Ga]Ga-ABY-025 was used as a HER2 specific radiotracer for PET imaging, for binary categorization of the ...