NCT05838729 is a Phase 1/Phase 2 clinical trial of RiMO-301 in Head Neck Cancer, sponsored by Coordination Pharmaceuticals, Inc..

Who is sponsoring NCT05838729?

NCT05838729 is sponsored by Coordination Pharmaceuticals, Inc..

What drugs are being tested in NCT05838729?

Interventions in NCT05838729: RiMO-301.

What condition does NCT05838729 study?

NCT05838729 studies Head Neck Cancer, Intratumoral Injection.

Is NCT05838729 still recruiting?

NCT05838729 is currently recruiting now. Last updated 11 September 2025.

Last reviewed 2025-09-11 · How we verify

NCT05838729

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

Phase 1b/2a Study of RiMO-301 and Hypofractionated Radiotherapy With A PD-1 Inhibitor for the Treatment of Unresectable, Recurrent or Metastatic Head-Neck Cancer

Recruiting now Phase 1/Phase 2 Last updated 11 September 2025

What this trial tests

Phase 1/Phase 2 trial testing RiMO-301 in Head Neck Cancer in 16 participants. Currently enrolling.

Timeline

3 April 2023

Primary endpoint
1 September 2026

1 December 2026

Quick facts

Lead sponsor	Coordination Pharmaceuticals, Inc.
Phase	Phase 1/Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	3 April 2023
Primary completion	1 September 2026
Estimated completion	1 December 2026
Sites	1 location across United States

Drugs / interventions tested

RiMO-301 — full drug profile →

Conditions studied

Head Neck Cancer — all drugs for Head Neck Cancer →
Intratumoral Injection — all drugs for Intratumoral Injection →

Sponsor

Coordination Pharmaceuticals, Inc. — full company profile →

Who can join

18 and older, any sex, with Head Neck Cancer or Intratumoral Injection. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Determination of Recommended Dose
Time frame: 6 weeks
• The dose limiting toxicities of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor, as assessed by CTCAEv5, will not be observed in 33% or more patients
Evaluation of Anti-Tumor Response
Time frame: 12 months
• To determine the objective response rate: complete or partial response, as defined by RECIST and itRECIST

Sponsor's own description

This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with hypofractionated radiation and a PD-1 Inhibitor in patients with unresectable, recurrent or metastatic head-neck cancer.

Publications & conference data

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

Biomedical Metal-Organic Framework Materials: Perspectives and Challenges.
Wang A, Walden M, Ettlinger R, Kiessling F, et al · · 2024 · cited 66× · PMID 39726715 · DOI 10.1002/adfm.202308589
Metal-organic framework-based smart stimuli-responsive drug delivery systems for cancer therapy: advances, challenges, and future perspectives.
Guo Z, Xiao Y, Wu W, Zhe M, et al · · 2025 · cited 35× · PMID 40022098 · DOI 10.1186/s12951-025-03252-x
Nanotechnology for immuno-oncology.
Grippin AJ, Lee D, Parkes EE, Jiang W, et al · · 2025 · cited 7× · PMID 40775548 · DOI 10.1038/s43018-025-01025-x
Metallic nanomedicine in cancer immunotherapy.
Li S, Wang X, Han H, Xiang S, et al · · 2025 · cited 2× · PMID 41049749 · DOI 10.1016/j.apsb.2025.07.017
In Situ Vaccines in the Era of Cancer Immunotherapy: Conceptual Innovation and Clinical Translation.
Shi Y, Hou Y, Mabrouk MT, Yu C, et al · · 2025 · cited 1× · PMID 40827547 · DOI 10.1002/advs.202509836
Current Perspectives on Radiosensitizers in Cancer Radiotherapy
Ruan H, Li Y, Chen S. · · 2026

Verify or expand the search:

Other trials of RiMO-301

Trials testing the same drug.

NCT03444714 — Phase I Study of RiMO-301 With Radiation in Advanced Tumors · Phase 1 · completed

Other recruiting trials for Head Neck Cancer

Currently open trials in the same condition.

NCT07405645 — Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy · NA · recruiting
NCT06736379 — Intratumoral Delivery of Viral Replicon (saRNA) Particles Expressing IL-12 in Head and Neck Cancer · Phase 1 · recruiting
NCT06642324 — Human Papillomavirus Association and Genomic Exploration in Head-Neck Squamous Cell Carcinomas · recruiting
NCT05878964 — Evaluation of Skin Health and QoL in Pts Receiving Anti-PD1/PDL1/CTLA4 or CDK Inhibitors. · recruiting
NCT05382585 — Newer Therapeutic Targets in Head and Neck Cancers · recruiting

Other Coordination Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT06182579 — Phase I Study of RiMO-401 With Radiation in Advanced Tumors · Phase 1 · terminated
NCT04808453 — Phase I Study of CPI-300 in Patients With Advanced Tumors · Phase 1 · completed
NCT03953742 — Study of CPI-200 in Patients With Advanced Tumors · Phase 1 · completed
NCT03781362 — Study of CPI-100 in Patients With Advanced Tumors · Phase 1 · completed
NCT03444714 — Phase I Study of RiMO-301 With Radiation in Advanced Tumors · 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 NCT05838729 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 Coordination Pharmaceuticals, Inc.
Last refreshed: 11 September 2025

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/NCT05838729.

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