TheranosticTrials.org

Clinical Trial · NCT06389123

Molecularly Targeted Theranostic Approach for the Detection and Treatment of Metastatic Carcinomas

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 cancer.

Sponsor

University of California, Davis

Phase

Phase 1

Contacts

Julie L Sutcliffe (PRINCIPAL_INVESTIGATOR)

Julie L Sutcliffe (CONTACT)

jlsutcliffe@ucdavis.edu

9167345536

Julie L Sutcliffe, Phd (CONTACT)

jlsutcliffe@ucdavis.edu

9167345536

ClinicalTrials.gov

NCT06389123

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
Linker: ABM

Eligibility

Inclusion

  • 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.
  • Pathologically confirmed GU, GI, GYN breast, cervical, uterine, or head and neck cancers 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)

Exclusion

Exclusion criteria not yet provided.