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

Navidea Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Kaposi Sarcoma; HIV Infections

Treatments: Drug: Tc99m-tilmanocept

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT03157167

NAV3-24

1R44CA192859-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

This is a Manocept Platform prospective, single-center, open-label, non-randomized, dose escalation, comparative, safety study of intravenously and subcutaneously injected Tc 99m tilmanocept in the localization and detection of cutaneous and non-cutaneous KS tumor(s) in subjects with biopsy-confirmed KS. Three IV doses (µg/mCi) of tilmanocept will be evaluated in three cohort groups. One subcutaneous dose will be evaluated in cohort group 3.

This study is designed to evaluate the safety and tolerability of escalating doses of IV Tc 99m tilmanocept and to compare results obtained from IV and subcutaneous administrations of Tc 99m tilmanocept in the same subjects. Whole body planar as well as SPECT/CT imaging will be performed to provide greater resolution of areas of Tc 99m tilmanocept localization. A biopsy of a non-visceral KS lesion will be taken to correlate pathology with Tc 99m tilmanocept localization.

This study is designed to evaluate the use of Tc 99m tilmanocept as an imaging agent in HIV-positive subjects with known KS by evaluating localization in known and unknown cutaneous and non-cutaneous lesions.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The subject has provided written informed consent with HIPAA authorization before the initiation of any study-related procedures.

2. The subject is at least 18 years of age at the time of consent.

3. The subject is HIV positive.

4. The subject has a biopsy-confirmed diagnosis of KS and is classified into one of the categories below:

   1. Confirmed cutaneous KS/oral lesions without edema.
   2. Confirmed cutaneous KS/oral lesions with edema.
   3. 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

1. The subject is pregnant or lactating.
2. The subject has received chemotherapy or radiation therapy to KS sites within six weeks of enrollment.
3. The subject has known sensitivity to dextran.
4. The subject has received an investigational product within 30 days prior to the Tc 99m tilmanocept administration on Day 1.
5. The subject has received any radiopharmaceutical within 7 days prior to the administration of Tc 99m tilmanocept on Day 1.
6. 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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

100 mcg/5 mCi Tc99m-Tilmanocept

Experimental group

Description:

Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.

Treatment:

Drug: Tc99m-tilmanocept

100 mcg/10 mCi Tc99m-Tilmanocept

Experimental group

Description:

Four subjects will receive a single IV injection of 100 micrograms of Tc99m tilmanocept radiolabeled with 10 mCi.

Treatment:

Drug: Tc99m-tilmanocept

200 mcg/5 mCi Tc99m-Tilmanocept

Experimental group

Description:

Up to six subjects will receive a single subcutaneous injection and a single IV injection of 200 micrograms of Tc99m tilmanocept radiolabeled with 5 mCi.

Treatment:

Drug: Tc99m-tilmanocept