Phase 1
N=15
An Evaluation of Tc 99m Tilmanocept by Intravenous (IV) and Subcutaneous (SC) Injection in Kaposi Sarcoma (KS)
Kaposi Sarcoma · HIV Infections
Bottom Line
View on ClinicalTrials.gov: NCT03157167 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: To Determine the Safety of Escalating Doses of Tc 99m Tilmanocept in HIV Subjects With Biopsy-confirmed KS. — 0; 0; 0 Safety Signals
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Tc99m-tilmanocept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Navidea Biopharmaceuticals
- Primary completion
- Nov 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine the Safety of Escalating Doses of Tc 99m Tilmanocept in HIV Subjects With Biopsy-confirmed KS. |
0; 0; 0 | — |
| SECONDARY Per Subject Localization Rate of Tc 99m Tilmanocept in at Least One KS Suspected or Confirmed Lesion by Planar and/or SPECT/CT Imaging |
4; 1; 0; 0; 0; 4 | — |
| SECONDARY Qualify and Quantify Tc 99m Tilmanocept Localization Intensity on Imaging With CD206 Locale and Quantity by Histology and IHC in Biopsied KS Lesions to Determine Optimal IV Dose. |
4; 6; 0; 1; 1; 0 | — |
| SECONDARY Localization Concordance of Subcutaneous Injection and IV Injection |
3; 0; 0; 1 | — |
| SECONDARY Exploratory: Quantify HHV8 in Biopsied KS Lesions. Mean and Standard Deviation Results. |
1242.50; 4392.50 | — |
| SECONDARY Exploratory: Quantify HHV8 in Biopsied KS Lesions. Median Results. |
1171.50; 4463.50 | — |
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.
Eligibility Criteria
Inclusion Criteria
- The subject has provided written informed consent with HIPAA authorization before the initiation of any study-related procedures.
- The subject is at least 18 years of age at the time of consent.
- The subject is HIV positive.
- The subject has a biopsy-confirmed diagnosis of KS and is classified into one of the categories below:
- Confirmed cutaneous KS/oral lesions without edema.
- Confirmed cutaneous KS/oral lesions with edema.
- Confirmed cutaneous KS/oral lesions with or without edema and suspected non-cutaneous KS due to clinical symptomology or confirmed non-cutaneous KS lesion(s).
Exclusion Criteria
- The subject is pregnant or lactating.
- The subject has received chemotherapy or radiation therapy to KS sites within six weeks of enrollment.
- The subject has known sensitivity to dextran.
- The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration on Day 1.
- The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept on Day 1.
- Any condition that, in the clinical judgment of the treating physician, is likely to prevent the subject from complying with any aspect of the protocol or that may put the subject at unacceptable risk.
Data sourced from ClinicalTrials.gov (NCT03157167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.