A Novel Molecularly Targeted Theranostic Approach Via the αvβ6 Integrin for the Detection and Treatment of Metastatic Carcinomas
University of California, Davis
Summary
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.
Description
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. \[68Ga\]Ga DOTA-5G PET/CT will be used to identify and stratify patients eligible for (and most likely to respond to) the \[177Lu\]Lu DOTA-ABM-5G therapy. Up to 40 patients will be enrolled over a 36-month period with metastatic cancer with a life expectancy of at least 3 months, who demonstrate disease progression after at least 1 prior treatment for metastatic disease and have available archival tissue. The hypothesis are tha…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: \[68Ga\]Ga DOTA-5G PET/CT Inclusion Criteria: 1. Ability to understand and willingness to sign a written informed consent document. 2. Age 18 or more years 3. Pathologically confirmed GU, GI, GYN breast, cervical, uterine, or head and neck cancers 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) 4. Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen (Androgen Deprivation allowed) as establi…
Interventions
- Drug[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Patients 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.
Location
- The University of California Davis Comprehensive Cancer CenterSacramento, California