Clinical Trials Logo

Clinical Trial 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 non small cell lung cancer (NSCLC).


Clinical Trial 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 NSCLC. [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 NSCLC 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. We hypothesize that a) [68Ga]Ga DOTA-5G will detect lesions in patients with metastatic NSCLC, b) the theranostic pair [68Ga]Ga DOTA-5G/ [177Lu]Lu DOTA-ABM-5G will be safe and well tolerated, and c) a therapeutic response will be achieved with a single dose of [177Lu]Lu DOTA-ABM-5G. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06228482
Study type Interventional
Source University of California, Davis
Contact Julie L Sutcliffe, Phd
Phone 9167345536
Email jlsutcliffe@ucdavis.edu
Status Recruiting
Phase Phase 1
Start date January 22, 2024
Completion date January 2026

See also
  Status Clinical Trial Phase
Recruiting NCT03987555 - Paclitaxel Therapeutic Drug Monitoring in Cancer Patients
Completed NCT03512847 - Predictive Gene Profiles and Dynamic Measurement of Treatment Response in Metastatic Non-small Cell Lung Cancer
Completed NCT03415126 - A Study of ASN007 in Patients With Advanced Solid Tumors Phase 1
Completed NCT03825510 - Immunotherapy SBRT Sensitization of the Programmed Death-1 (PD-1) Effect Phase 2