NCT04272333

Intratumoral Microdosing of Motolimod in HNSCC

Terminated EARLY_PHASE1 Last updated 14 April 2022

What this trial tests

EARLY_PHASE1 trial testing Motolimod in HNSCC in 1 participant. Terminated before completion.

Timeline

15 October 2021

Primary endpoint
25 March 2022

25 March 2022

Quick facts

Lead sponsor	Presage Biosciences
Phase	EARLY_PHASE1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	1
Start date	15 October 2021
Primary completion	25 March 2022
Estimated completion	25 March 2022
Sites	5 locations across United States

Drugs / interventions tested

• Motolimod — full drug profile →
• Nivolumab (nivolumab) — full drug profile →
• Motolimod + Nivolumab

Conditions studied

• HNSCC — all drugs for HNSCC →

Sponsor

Presage Biosciences — full company profile →

Who can join

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

Sponsor's own description

This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic biomarker Phase 0 trial designed to study the biological effects within the tumor microenvironment of motolimod and motolimod combined with nivolumab when administered intratumorally in microdose quantities via the CIVO device in patients with head and neck squamous cell carcinoma (HNSCC). CIVO stands for comparative in vivo oncology.

Publications & conference data

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

1. Type I interferon-mediated tumor immunity and its role in immunotherapy.
   Yu R, Zhu B, Chen D. · · 2022 · cited 229× · PMID 35292881 · DOI 10.1007/s00018-022-04219-z
2. Harnessing innate immune pathways for therapeutic advancement in cancer.
   Hu A, Sun L, Lin H, Liao Y, et al · · 2024 · cited 150× · PMID 38523155 · DOI 10.1038/s41392-024-01765-9
3. Trial Watch: experimental TLR7/TLR8 agonists for oncological indications.
   Frega G, Wu Q, Le Naour J, Vacchelli E, et al · · 2020 · cited 84× · PMID 32934889 · DOI 10.1080/2162402x.2020.1796002
4. Senescence in the Development and Response to Cancer with Immunotherapy: A Double-Edged Sword.
   Battram AM, Bachiller M, Martín-Antonio B. · · 2020 · cited 49× · PMID 32570952 · DOI 10.3390/ijms21124346
5. Trial watch: intratumoral immunotherapy.
   Humeau J, Le Naour J, Galluzzi L, Kroemer G, et al · · 2021 · cited 45× · PMID 34676147 · DOI 10.1080/2162402x.2021.1984677
6. Targeting nuclear acid-mediated immunity in cancer immune checkpoint inhibitor therapies.
   Chen M, Hu S, Li Y, Jiang TT, et al · · 2020 · cited 32× · PMID 33214545 · DOI 10.1038/s41392-020-00347-9
7. Current Insights and Advancements in Head and Neck Cancer: Emerging Biomarkers and Therapeutics with Cues from Single Cell and 3D Model Omics Profiling.
   Jawa Y, Yadav P, Gupta S, Mathan SV, et al · · 2021 · cited 13× · PMID 34490084 · DOI 10.3389/fonc.2021.676948
8. Targeting pattern recognition receptors for cancer therapy: Mechanisms and strategies.
   Ouyang D, Chen R, Xie H, Yang X, et al · · 2025 · cited 1× · PMID 41311391 · DOI 10.1016/j.apsb.2025.09.007