CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 15 enrolled
Drug / intervention
Tc99m-tilmanoceptdrug
Likely dose
Escalating doses of Tc99m-tilmanocept by IV or SC injection (specific dose levels not stated)AI-extracted
Key inclusion· 3
  • ✓HIV positive
  • ✓Biopsy-confirmed Kaposi sarcoma: cutaneous/oral lesions with or without edema, or suspected/confirmed non-cutaneous KS
  • ✓Age ≥18 years
Key exclusion· 5
  • ✕Pregnant or lactating
  • ✕Chemotherapy or radiation therapy to KS sites within 6 weeks of enrollment
  • ✕Known sensitivity to dextran
  • ✕Investigational product within 30 days prior to study drug administration

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03157167
NCT03157167Phase 1Completed
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An Evaluation of the Safety of Escalating Doses of Tc 99m Tilmanocept by Intravenous (IV) Injection and a Comparison to Subcutaneous (SC) Injection in Human Immunodeficiency Virus (HIV) Subjects Diagnosed With Kaposi Sarcoma (KS)

Navidea Biopharmaceuticals·interventional·Posted May 17, 2017·Updated Mar 5, 2025

In Brief

A Phase 1 clinical trial evaluating Tc99m-tilmanocept for Kaposi Sarcoma and HIV Infections. Completed, enrolled 15 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKaposi Sarcoma, HIV Infections
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Cancer Institute (NCI)

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedMay 17, 2017
Enrollment StartDec 1, 2017
Primary CompletionNov 5, 2019
Study CompletionMar 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.1 years ago

Interventions

Tc99m-tilmanoceptdrug

Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.