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

NCT03157167 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: NAV3-241R44CA192859-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kaposi Sarcoma; HIV Infections

Keywords

Kaposi Sarcoma, KS, HIV

Outcome Measures

Primary Outcomes (1)

• To Determine the Safety of Escalating Doses of Tc 99m Tilmanocept in HIV Subjects With Biopsy-confirmed KS.

  Cohort 1 (100 mcg/ 5mCi) was conducted first. A safety data review meeting was held after completion of Cohort 1 and again after completion of Cohort 2 at which the principal investigators and sponsor representatives reviewed the safety data to determine whether to proceed to the next cohort. All cohorts were evaluated for safety. Safety evaluations included AEs, clinical laboratory tests, vital signs, physical examinations, and ECGs. The data table includes the number of safety signals detected during the evaluation for each cohort.

  10 days after IV Tc 99m tilmanocept administration

Secondary Outcomes (5)

• Per Subject Localization Rate of Tc 99m Tilmanocept in at Least One KS Suspected or Confirmed Lesion by Planar and/or SPECT/CT Imaging

  10 days after IV Tc 99m tilmanocept administration

• 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.

  10 days after IV Tc 99m tilmanocept administration

• Localization Concordance of Subcutaneous Injection and IV Injection

  10 days after IV Tc 99m tilmanocept administration

• Exploratory: Quantify HHV8 in Biopsied KS Lesions. Mean and Standard Deviation Results.

  10 days after IV Tc 99m tilmanocept administration

• Exploratory: Quantify HHV8 in Biopsied KS Lesions. Median Results.

  10 days after IV Tc 99m tilmanocept administration

Study Arms (3)

100 mcg/5 mCi Tc99m-Tilmanocept

EXPERIMENTAL

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

Drug: Tc99m-tilmanocept

100 mcg/10 mCi Tc99m-Tilmanocept

EXPERIMENTAL

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

Drug: Tc99m-tilmanocept

200 mcg/5 mCi Tc99m-Tilmanocept

EXPERIMENTAL

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.

Drug: Tc99m-tilmanocept

Interventions

Tc99m-tilmanocept DRUG

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

Also known as: Lymphoseek

100 mcg/10 mCi Tc99m-Tilmanocept; 100 mcg/5 mCi Tc99m-Tilmanocept; 200 mcg/5 mCi Tc99m-Tilmanocept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Navidea Biopharmaceuticals: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Zuckerberg San Francisco General Hospital

San Francisco, California, 94143, United States

Location

Related Publications (2)

• Cope, F.O., W. Metz, et al. Innovations in receptor-targeted precision imaging at Navidea: diagnosis up close and personal. Nature Outlook (31 October 2013); S125-S129.

  BACKGROUND

• Cope FO, Abbruzzese B, Sanders J, Metz W, Sturms K, Ralph D, Blue M, Zhang J, Bracci P, Bshara W, Behr S, Maurer T, Williams K, Walker J, Beverly A, Blay B, Damughatla A, Larsen M, Mountain C, Neylon E, Parcel K, Raghuraman K, Ricks K, Rose L, Sivakumar A, Streck N, Wang B, Wasco C, Williams A, Schlesinger LS, Azad A, Rajaram MVS, Jarjour W, Young N, Rosol T, McGrath M. Corrigendum to the inextricable axis of targeted diagnostic imaging and therapy: An immunological natural history approach [Nucl Med Biol 43 (2016) 215-225]. Nucl Med Biol. 2016 Dec;43(12):837. doi: 10.1016/j.nucmedbio.2016.10.001. No abstract available.

  PMID: 27866590 RESULT

MeSH Terms

Conditions

Sarcoma, Kaposi; HIV Infections

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Michael Blue, MD
• Organization: Navidea Biopharmaceuticals

mblue@navidea.com

6145714313

Study Officials

• Michael Blue, MD

  Navidea Biopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 17, 2017
• Study Start: December 1, 2017
• Primary Completion: November 5, 2019
• Study Completion: March 30, 2020
• Last Updated: March 5, 2025
• Results First Posted: March 5, 2025

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)