This phase I trial tests the safety, side effects and effectiveness of gallium Ga 68-DOTA-5G ([68Ga]Ga DOTA-5G) and lutetium Lu 177-DOTA-ABM-5G ([177Lu]Lu DOTA-ABM-5G) in detecting and treating cancers that have spread from where they first started (primary site) to other places in the body (metastatic). The radioactive study drugs, [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G, attach to a protein on the surface of tumor cells. When gallium-68 is attached, these radioactive molecules can be used to detect tumor cells using positron emission tomography (PET)/ computed tomography (CT) scans. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, [68Ga]Ga DOTA-5G. Because some cancers take up [68Ga]Ga DOTA-5G, it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. These radioactive molecules can also be used to treat tumors (when lutetium-177 is attached). This pair of radiotracers is termed a “theranostic pair” because [68Ga]Ga DOTA-5G can be used for the diagnosis and to determine the extent of disease, while [177Lu]Lu DOTA-ABM-5G can be used for treatment by delivering radioactivity to the tumor. A theranostic approach with [68Ga]Ga DOTA-5G and [177]Lu DOTA-ABM-5G may be safe, tolerable and/or effective in detecting and treating metastatic cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06389123.
Locations matching your search criteria
United States
California
Sacramento
University of California Davis Comprehensive Cancer CenterStatus: Active
Contact: Julie Sutcliffe
Phone: 916-734-5536
PRIMARY OBJECTIVES:
I. To assess the ability of gallium Ga 68-tetra-azacyclododecane-tetra-acetic acid-5G ([68Ga]Ga DOTA-5G) to detect lesions.
II. To evaluate the safety and tolerability of [68Ga]Ga DOTA-5G and lutetium Lu 177-tetra-azacyclododecane-tetra-acetic acid-albumin-binding moiety-5G ([177Lu]Lu DOTA-ABM-5G).
III. To assess treatment efficacy.
SECONDARY OBJECTIVES:
I. To assess treatment response (response versus [vs.] no response) according to Response Evaluation Criteria in Solid Tumors (RECIST) (version [v]1.1) assessed by comparison with a post-treatment [68Ga]Ga DOTA-5G PET/CT.
II. To evaluate alpha-V beta 6 levels (ng/mL) in blood pre and post [177Lu]Lu DOTA-ABM-5G treatment.
III. From single photon emission computed tomography (SPECT)/CT dosimetry evaluate:
IIIa. Area under the curve (AUC) of [177Lu]Lu DOTA-ABM-5G in target lesion;
IIIb. Maximum uptake at the target lesion;
IIIc. Maximum uptake in discernible organs;
IIId. Other dosimetry outcomes including specific absorbed dose per organ (uGy/MBq) and cumulative absorbed organ doses (Gy).
OUTLINE:
Patients receive [68Ga]Ga DOTA-5G intravenously (IV) and undergo PET/CT over 30 minutes at 60 and 120 minutes after infusion. Within 4 weeks, patients with detectable cancer receive [177Lu]Lu DOTA-ABM-5G IV then undergo SPECT/CT at 24 hours and 168 hours after infusion. Patients also receive [68Ga]Ga DOTA-5G IV and undergo PET/CT on day 30 after treatment. Additionally, patients undergo blood sample collection throughout the study.
After completion of study treatment, patients are followed for at least 5 years or until death.
Lead OrganizationUniversity of California Davis Comprehensive Cancer Center
Principal InvestigatorJulie Sutcliffe
