Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06228482

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

Led by University of California, Davis · Updated on 2026-02-27

40

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

Sponsors

U

University of California, Davis

Lead Sponsor

U

United States Department of Defense

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Ability to understand and sign informed consent
  • Age 18 years or older
  • Confirmed metastatic non-small cell lung cancer with measurable disease
  • Documented tumor progression after at least one prior FDA-approved treatment
  • Available archival tumor tissue, preferably from metastatic site
  • Eastern Cooperative Oncology Group Performance Status of 2 or less
  • Completed prior systemic therapy at least 2 weeks before PET scan with resolved toxicities except hair loss and sensory neuropathy
  • Blood counts: absolute neutrophil count ≥ 1000 cells/mm3, platelet count ≥ 100,000/mm3, hemoglobin ≥ 8 g/dL
  • Blood chemistry: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal, total bilirubin ≤ 2 times upper limit of normal, creatinine ≤ 2 times upper limit of normal
  • Life expectancy of at least 3 months
  • Ability to remain motionless for 30-60 minutes during scan
  • Completion of [68Ga]Ga DOTA-5G PET/CT scan
  • At least one measurable lesion on PET/CT with SUVmax > 2 times above normal tissues
Not Eligible

You will not qualify if you...

  • Class 3 or 4 New York Heart Association congestive heart failure
  • Significant bleeding within 2 weeks prior to enrollment
  • Pregnant or breastfeeding women
  • Major surgery within 28 days prior to study or planned surgery within 6 weeks
  • Active additional malignancy requiring therapy within past 2 years except certain early-stage skin and in situ cancers
  • Active, uncontrolled infections despite treatment
  • Psychiatric or social conditions interfering with study compliance
  • Weight above PET/CT or SPECT/CT scanner limit (350 lbs)
  • Known interstitial lung disease or pre-existing pulmonary fibrosis
  • INR greater than 2.0 or PTT more than 15 seconds above upper limit of normal

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The University of California Davis Comprehensive Cancer Center

Sacramento, California, United States, 95817

Actively Recruiting

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Research Team

J

Julie L Sutcliffe, Phd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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