This is a Phase I study to evaluate the safety and efficacy of the \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G theranostics pair in patients with metastatic cancer.
Ability to understand and willingness to sign a written informed consent document.
Age 18 or more years
Pathologically confirmed solid cancer with metastatic disease and measurable disease per RECIST (version 1.1) (i.e. at least 1 lesion > 1 cm or lymph node > 1.5 cm in short axis) or PERCIST.
Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as established by diagnostic imaging.
Participants with Class 3 or 4 NYHA Congestive Heart Failure
Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)
Pregnant or lactating women
Major surgery, defined as any surgical procedure that involves general anesthesia and a significant incision (i.e., larger than what is required for placement of a central venous access, percutaneous feeding tube, or biopsy) within 28 days prior to study day 1 or anticipated surgery within the subsequent 6 weeks
Single group
[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
DrugPatients will be undergo \[68Ga\]Ga DOTA-5G PET/CT scans to confirm eligibility for the \[177Lu\]Lu DOTA-ABM-5G therapy. Patients with sufficient lesion uptake of \[68Ga\]Ga DOTA-5G PET/CT will be offered therapy. Patients will undergo a follow up \[68Ga\]Ga DOTA-5G PET/CT scans to assess tretament efficacy.
[68Ga]Ga DOTA-5G PET/CT imaging
To assess the ability of \[68Ga\]Ga DOTA-5G to detect lesions in patients with metastatic cancer
[177Lu]Lu DOTA-ABM-5G treatment
To assess the safety and tolerability of a single treatment with \[177Lu\]Lu DOTA-ABM-5G
[177Lu]Lu DOTA-ABM-5G treatment efficacy
To assess treatment efficacy (response vs. no response) assessed by comparison with a post-treatment scan (standard of care imaging and post second \[68Ga\]Ga DOTA-5G PET/CT, prior to next line of therapy.
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University of California, Davis
Lead sponsor
National Institutes of Health (NIH)
Collaborator
