TheranosticTrials.org

Clinical Trial · NCT05408871

Non-invasive Measurement of PD-L1 Levels With Positron Emission Tomography (PET) in Head and Neck Malignancies and Intracranial Metastases

Overview

This study aims to determine the feasibility of non-invasive quantitative PD-L1 measurement using \[a novel PD-L1 positron emission tomography (PET) tracer and perform immunohistochemistry based measurement of PD-L1 levels within resected lesions in head and neck cancer and brain metastases.

Sponsor

Duke University

Phase

Phase 1

Contacts

Mariam S Aboian, MD PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05408871

Drug / Compound

PDL192

Isotope(s):
Target(s):
  • PD-L1
Ligand Class: Small Proteins and Antibody Fragments

Eligibility

Inclusion

  • Absolute neutrophil count (ANC) \> 1500/microliter, absolute lymphocyte count (ALC) \>1000/microliter, hemoglobin \> 9 g/dl, platelets \> 100,000/microliter
  • Receipt of other systemic therapy including investigational agents, radiation or gross resection for treatment of the tumor under study.Exclusion Criteria for Brain Metastases:
  • Absolute neutrophil count (ANC) \> 1500/microliter, absolute lymphocyte count (ALC) \>1000/microliter, hemoglobin \> 9 g/dl, platelets \> 100,000/microliter.
  • Medical contraindication to brain surgery.
  • AST and ALT \< 5 x upper limit of normal. Bilirubin \< 1.5 x upper limit of normal.
  • Women may not be pregnant or breast-feeding.
  • Full dose anticoagulation.
  • Patients with resectable squamous cell carcinoma of the oropharynx (HPV positive and HPV negative).
  • Resectability or need for laser interstitial thermal therapy (LITT) will be confirmed by a surgical co-investigator.
  • aspartate aminotransferase (AST) and alanine transaminase (ALT) \< 5 x upper limit of normal. Bilirubin \< 1.5 x upper limit of normal.
  • Patients with brain metastases
  • Creatinine \< 5 x upper limit of normal.
  • Prior systemic therapy, radiation or gross resection for the tumor under study.
  • Full dose anticoagulation.
  • Medical contraindication to surgery.
  • Creatinine \< 5 x upper limit of normal.

Exclusion

Exclusion criteria not yet provided.