TheranosticTrials.org

Clinical Trial · NCT06228482

Molecularly Targeted Radionuclide Therapy Via the Integrin Alphavbeta6

Overview

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).

Sponsor

University of California, Davis

Phase

Phase 1

Contacts

Julie L Sutcliffe, PhD (PRINCIPAL_INVESTIGATOR)

Julie L Sutcliffe, Phd (CONTACT)

jlsutcliffe@ucdavis.edu

9167345536

ClinicalTrials.gov

NCT06228482

Drug / Compound

DOTA-5G

Isotope(s):
Target(s):
  • αvβ6
Ligand Class: Peptides
Chelator: DOTA

DOTA-ABM-5G

Isotope(s):
Target(s):
  • αvβ6
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • 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)
  • The presence of at least one measurable disease by \[68Ga\]Ga DOTA-5G PET/CT (SUVmax\>2-fold above normal bone, brain, lung or liver and identified on standard of care diagnostic imaging) Patients with a history of brain metastases and or any clinical concern for brain metastases will be evaluated with brain MRI as per standard of care for patients with metastatic NSCLC.
  • 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.
  • Blood chemistry levels defined as: AST, ALT, alkaline phosphatase ≤ 5 times upper limit of normal (ULN) Total bilirubin ≤ 2 times ULN Creatinine ≤ 2 times ULN
  • Able to remain motionless for up to 30-60 minutes per scan\[177Lu\]Lu DOTA-ABM-5G therapy Inclusion Criteria:
  • Participant must have completed prior systemic therapy at least 2 weeks (washout period) prior to \[68Ga\]Ga DOTA-5G PET scan. Any clinically significant toxicity (with the exceptions of hair loss and sensory neuropathy) related to prior therapy resolved to Grade 1 or baseline.
  • Hematologic parameters defined as: Absolute neutrophil count (ANC) ≥ 1000 cells/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 8 g/dL
  • \[68Ga\]Ga DOTA-5G PET/CT Inclusion Criteria:
  • Eastern Cooperative Oncology Group Performance Status ≤ 2
  • Available archival tumor tissue (excisional, core, or FNA is acceptable). Tissue from a metastatic site is preferred when available.
  • Anticipated life expectancy ≥ 3 months
  • Completion of entry into \[68Ga\]Ga DOTA-5G PET study and completion of scan

Exclusion

  • Psychiatric illness/social situations that would interfere with compliance with study requirements
  • \[68Ga\]Ga DOTA-5G and \[177Lu\]Lu DOTA-ABM-5G therapy Exclusion Criteria:
  • INR \>2.0: PTT\>15 seconds above ULN
  • Participants with Class 3 or 4 NYHA Congestive Heart Failure
  • Known interstitial lung disease or pre-existing pulmonary fibrosis
  • Active, uncontrolled bacterial, viral, or fungal infection(s) despite systemic therapy
  • 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
  • Pregnant or lactating women
  • Cannot undergo PET/CT or SPECT/CT scanning because of weight limits (350 lbs.)
  • Clinically significant bleeding within two weeks prior to trial. entry (e.g. gastrointestinal bleeding, intracranial bleeding)