Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6
ConditionMetastatic Nonsmall Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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).
Eligibility criteria
Qualifiers
Ability to understand and willingness to sign a written informed consent document.
Age 18 or more years
Pathologically confirmed NSCLC 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)
Participant must have documented tumor progression for metastatic disease during or following at least one prior FDA approved systemic regimen as established by diagnostic imaging.
Disqualifiers
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
Trial design
Treatments tested in this trial
- [68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, Davis
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov