NCT04065555 is a EARLY_PHASE1 clinical trial of TAK-981 in Head and Neck Cancer, sponsored by Presage Biosciences.

Who is sponsoring NCT04065555?

NCT04065555 is sponsored by Presage Biosciences.

What drugs are being tested in NCT04065555?

Interventions in NCT04065555: TAK-981, Cetuximab, Avelumab, TAK-981 + Cetuximab, TAK-981 + Avelumab.

What condition does NCT04065555 study?

NCT04065555 studies Head and Neck Cancer.

Is NCT04065555 still recruiting?

NCT04065555 is currently completed. Last updated 29 July 2022.

Last reviewed 2022-07-29 · How we verify

NCT04065555

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Intratumoral Microdosing of TAK-981 in Head and Neck Cancer

Completed EARLY_PHASE1 Last updated 29 July 2022

What this trial tests

EARLY_PHASE1 trial testing TAK-981 in Head and Neck Cancer in 12 participants. Completed in 20 July 2022.

Timeline

7 October 2020

Primary endpoint
20 June 2022

20 July 2022

Quick facts

Lead sponsor	Presage Biosciences
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	7 October 2020
Primary completion	20 June 2022
Estimated completion	20 July 2022
Sites	6 locations across United States

Drugs / interventions tested

TAK-981 — full drug profile →
Cetuximab (cetuximab) — full drug profile →
Avelumab (avelumab) — full drug profile →
TAK-981 + Cetuximab
TAK-981 + Avelumab

Conditions studied

Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

Presage Biosciences — full company profile →

Who can join

18 and older, any sex, with Head and Neck Cancer. 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 TAK-981 and TAK-981 combined with cetuximab or avelumab when administered intratumorally in microdose quantities via the CIVO device. CIVO stands for comparative in vivo oncology.

Publications & conference data

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

Ubiquitination and deubiquitination in cancer: from mechanisms to novel therapeutic approaches.
Liu F, Chen J, Li K, Li H, et al · · 2024 · cited 195× · PMID 39048965 · DOI 10.1186/s12943-024-02046-3
Targeting pancreatic cancer by TAK-981: a SUMOylation inhibitor that activates the immune system and blocks cancer cell cycle progression in a preclinical model.
Kumar S, Schoonderwoerd MJA, Kroonen JS, de Graaf IJ, et al · · 2022 · cited 110× · PMID 35074907 · DOI 10.1136/gutjnl-2021-324834
Therapeutic Potential of Targeting the SUMO Pathway in Cancer.
Kukkula A, Ojala VK, Mendez LM, Sistonen L, et al · · 2021 · cited 61× · PMID 34503213 · DOI 10.3390/cancers13174402
Ubiquitin and Ubiquitin-like Proteins in Cancer, Neurodegenerative Disorders, and Heart Diseases.
Hwang JT, Lee A, Kho C. · · 2022 · cited 49× · PMID 35563444 · DOI 10.3390/ijms23095053
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
The emerging roles of SUMOylation in the tumor microenvironment and therapeutic implications.
Gu Y, Fang Y, Wu X, Xu T, et al · · 2023 · cited 37× · PMID 37415251 · DOI 10.1186/s40164-023-00420-3
SUMOylation and NEDDylation in Primary and Metastatic Cancers to Bone.
Gomarasca M, Lombardi G, Maroni P. · · 2022 · cited 21× · PMID 35465332 · DOI 10.3389/fcell.2022.889002
Trackable Intratumor Microdosing and Spatial Profiling Provide Early Insights into Activity of Investigational Agents in the Intact Tumor Microenvironment.
Derry JMJ, Burns C, Frazier JP, Beirne E, et al · · 2023 · cited 20× · PMID 37389981 · DOI 10.1158/1078-0432.ccr-23-0827

Verify or expand the search:

Other trials of TAK-981

Trials testing the same drug.

NCT04776018 — A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) · Phase 1, PHASE2 · terminated
NCT04381650 — A Study of TAK-981 Given With Pembrolizumab in Participants With Select Advanced or Metastatic Solid Tumors · Phase 1, PHASE2 · completed
NCT04074330 — A Study of TAK-981 Given With Rituximab in Adults With Relapsed or Refractory CD20-Positive Non-Hodgkin Lymphoma · Phase 1, PHASE2 · terminated
NCT03648372 — A Study of TAK-981 in People With Advanced Solid Tumors or Cancers in the Immune System · Phase 1, PHASE2 · terminated

Other recruiting trials for Head and Neck Cancer

Currently open trials in the same condition.

NCT07318220 — Prehabilitation Protocol for Head and Neck Cancer Patients · NA · recruiting
NCT07524114 — Study of High-Precision Evaluation of Molecular ResiduaL Disease Through a PlatfOrm for Cancer TracKing and Interception · recruiting
NCT07467083 — Development and Application of a Nurse-Led Preemptive Symptom Management Protocol for Head and Neck Cancer Patients Unde · Phase 3 · recruiting
NCT07209189 — Neoadjuvant Chemotherapy and Programmed Cell Death Protein 1(PD-1) Inhibition for Head and Neck Cancer Treatment De-esca · Phase 2 · recruiting
NCT06837480 — Photobiomodulation in Head and Neck Cancer-Related Chronic Lymphedema · NA · recruiting

Other Presage Biosciences trials

Trials by the same sponsor.

NCT06413095 — PBI-MST-01 (NCT04541108) Substudy MSD-03: Intratumoral Microdosing of Pembrolizumab Alone and With MK-0482 or MK-4830 in · EARLY_PHASE1 · completed
NCT04272333 — Intratumoral Microdosing of Motolimod in HNSCC · EARLY_PHASE1 · terminated
NCT04891718 — CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia · EARLY_PHASE1 · withdrawn
NCT06062602 — PBI-MST-01(NCT04541108) Substudy TAK-02: Intratumoral Microdosing of TAK-676 in HNSCC · EARLY_PHASE1 · completed
NCT03056599 — Precise Local Injection of Anti-cancer Drugs Using Presage's CIVO Device in Soft Tissue Sarcoma · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04065555 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Presage Biosciences
Last refreshed: 29 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04065555.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing