NCT04663126: Tilmanocept

Feasibility of IV Tc-99m-tilmanocept for Imaging of M2-like TAMs in Metastatic Melanoma

Terminated EARLY_PHASE1 Last updated 13 December 2023

What this trial tests

EARLY_PHASE1 trial testing Tc-99m tilmanocept in Melanoma in 5 participants. Terminated before completion.

Timeline

1 February 2021

Primary endpoint
8 January 2023

19 June 2023

Quick facts

Lead sponsor	John O. Prior
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	5
Start date	1 February 2021
Primary completion	8 January 2023
Estimated completion	19 June 2023
Sites	1 location across Switzerland

Drugs / interventions tested

• Tc-99m tilmanocept

Conditions studied

• Melanoma — all drugs for Melanoma →

Sponsor

John O. Prior — full company profile →

Who can join

18 and older, any sex, with Melanoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study in 20 patients is designed as a monocentric, open-label and uncontrolled, exploratory pilot study. Patients diagnosed with advanced melanoma (stage III-IV) and scheduled for anti-PD-1 immunotherapy will be recruited for this project. Patients will receive IV 250 µg Tilmanocept, labelled with 370 MBq of Tc-99m (bolus injection) according to the Navidea's protocol in our GMP certified radiopharmaceutical unit, before the first cycle of clinically scheduled immunotherapy.

Scintigraphy images will be acquired dynamically from time of injection to +30 minutes. Quantitative SPECT/CT (xSPECT/CT, Siemens Symbia Intevo, Erlangen, Germany) imaging will be performed up to 1 hour p.i. to evaluate hyperaemia, and up to 3 hours p.i. to image and measure the CD206 receptor uptake. The data of the scans will be compared to immunohistochemistry results from biopsy staining for TAMs and M2-like TAMs and retrospectively with response to the immunotherapy to determine any correlation between M2-like TAMs and treatment response. For the planned retrospective comparison we will use the FDG - PET/CT data that is done after the immunotherapy as standard of care. We will analyse the lesion size and FDG - uptake in standard of care PET/CT of CD206+ and CD206 negative lesions in Tilmanocept SPECT/CT before and after immunotherapy to determine any correlation between CD206 related uptake and treatment response.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Unraveling the enigma of tumor-associated macrophages: challenges, innovations, and the path to therapeutic breakthroughs.
   Shao S, Miao H, Ma W. · · 2023 · cited 45× · PMID 38035068 · DOI 10.3389/fimmu.2023.1295684
2. Radionuclide imaging and therapy directed towards the tumor microenvironment: a multi-cancer approach for personalized medicine.
   van der Heide CD, Dalm SU. · · 2022 · cited 26× · PMID 35788730 · DOI 10.1007/s00259-022-05870-1
3. Utility of [^99mTc]Tc-tilmanocept, an immunosuppressive macrophage functional imaging agent in melanoma patients receiving checkpoint inhibitor treatment: a feasibility study.
   Boughdad S, Latifyan S, Schottelius M, Blue M, et al · · 2025 · PMID 40913745 · DOI 10.1007/s00262-025-04127-8