[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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment [68Ga]Ga-ABY-025 Imaging for Cancer?

[68Ga]Ga-ABY-025 has shown potential in detecting and measuring HER2, a protein involved in some breast cancers, in a phase I study. This suggests it could be useful in identifying and assessing certain types of cancer. ^{1 2 3 4 5}

Is [68Ga]Ga-ABY-025 safe for use in humans?

The articles reviewed do not provide specific safety data for [68Ga]Ga-ABY-025, but they discuss the use of gallium-68 in various imaging applications, suggesting it is generally used in clinical settings. However, specific safety information for [68Ga]Ga-ABY-025 itself is not available in the provided research. ^{1 6 7 8 9}

How does the [68Ga]Ga-ABY-025 imaging treatment differ from other cancer treatments?

[68Ga]Ga-ABY-025 imaging is unique because it uses gallium-68, a radionuclide that allows for PET imaging without needing a cyclotron, making it more accessible. This imaging technique can help identify specific biological targets in cancer, potentially leading to more personalized treatment options. ^{1 4 7 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 3 hours +/- 30minutes 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+

Findings from Research

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]

(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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Gallium-68: a systematic review of its nononcological applications. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Diagnostic HER2-binding radiopharmaceutical, [68Ga]Ga-ABY-025, for routine clinical use in breast cancer patients. [2020]

3. England pubmed.ncbi.nlm.nih.gov

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

4. Germany pubmed.ncbi.nlm.nih.gov

(68)Ga-labeled radiopharmaceuticals for positron emission tomography. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

6. United States 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. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Translational assessment of a DATA-functionalized FAP inhibitor with facile 68Ga-labeling at room temperature. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Development and long-term evaluation of a new 68Ge/68Ga generator based on nano-SnO2 for PET imaging. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

(68)Ga-labeled DOTA-peptides and (68)Ga-labeled radiopharmaceuticals for positron emission tomography: current status of research, clinical applications, and future perspectives. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Gallium-68: methodology and novel radiotracers for positron emission tomography (2012-2017). [2019]

11. Germany 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. [2021]