Clinical Trial · NCT03157167

An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS)

Overview

To determine the safety of escalating IV doses of Tc 99m tilmanocept in HIV (human immunodeficiency virus) subjects with confirmed KS and to compare results obtained from subcutaneous and IV administrations of Tc 99m tilmanocept in the same subjects.

Sponsor

Avid Radiopharmaceuticals

Phase

Phase 1

Contacts

Michael Blue, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT03157167

Drug / Compound

tilmanocept

Isotope(s):

Target(s):

Mannose Receptor (CD206/MRC1)

Ligand Class: Small Molecules

Eligibility

Inclusion

The subject is at least 18 years of age at the time of consent.
The subject is HIV positive.
Confirmed cutaneous KS/oral lesions without edema.
The subject has a biopsy-confirmed diagnosis of KS and is classified into one of the categories below:
1. The subject has provided written informed consent with HIPAA authorization before the initiation of any study-related procedures.

Exclusion

The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept on Day 1.
The subject has known sensitivity to dextran.
1. The subject is pregnant or lactating.
The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration on Day 1.
The subject has received chemotherapy or radiation therapy to KS sites within six weeks of enrollment.