TheranosticTrials.org

Clinical Trial · NCT04029181

ImmunoPET With an Anti-CD8 Imaging Agent

Overview

This is a single-center, single-arm, investigator sponsored trial designed to evaluate the PK of the anti-CD8 imaging agent in patients prior to and during treatment with checkpoint inhibitors.

Sponsor

University Medical Center Groningen

Phase

Phase 1/2

Contacts

E. G.E. de Vries, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04029181

Drug / Compound

anti-CD8 imaging agent

Isotope(s):
Target(s):
  • CD8 Cells
Ligand Class: Antibodies

Eligibility

Inclusion

  • Tumor lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
  • Cancer types other than melanoma; subjects meeting the eligibility criteria as formulated in the MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG) are eligible for part A or part B1.
  • Melanoma; subjects eligible to receive standard of care anti-PD1 therapy plus or minus ipilimumab, are eligible for part B2.
  • 1. Subjects with histologically confirmed locally advanced or metastatic cancer for the following tumor types
  • Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions.

Exclusion

  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • 1. Potential subjects with cancer other than melanoma will be excluded from participation in this study if they meet exclusion criteria formulated in the MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG).
  • Prior immune checkpoint inhibitor treatment, including but not limited to anti-PD1 and anti-PD-L1 therapeutic antibodies.
  • Signs or symptoms of infection within 2 weeks prior to anti-CD8 imaging agent injection.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the anti-CD8 imaging agent, or that may affect the interpretation of the results or render the patient at high risk from complications.