Recruiting
Phase 1
Phase 2

RiMO-301 & Radiotherapy

Sponsor:

Coordination Pharmaceuticals, Inc.

Code:

NCT05838729

Conditions

Head Neck Cancer

Intratumoral Injection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RiMO-301

Study Details

Brief summary:

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.

Conditions

Head Neck Cancer

Intratumoral Injection

Study ID

NCT05838729

Start date

Apr 3, 2023

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of head-neck cancer that requires palliative radiotherapy
  • Patients with unresectable, recurrent or metastatic HNSCC, regardless if the patients have progressed on or are intolerant to platinum-based chemotherapy prior to study enrollment or if the patients are receiving pembrolizumab in the first line:

  • receiving a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care, or
  • suitable to receive a PD-1 inhibitor (pembrolizumab or nivolumab) as a standard of care in the discretion of the treating physician or Principal Investigator
  • Must have at least 1 target lesion that is clinically accessible to RiMO-301 injection and amenable to receive RT regimens specified in this protocol
  • The selected target lesions must be measurable on cross-sectional imaging and repeated measurements at the same location should be achievable
  • Target tumor not in the previously irradiated field or in the field irradiated at least six months prior to RiMO-301 injection and with no complications from the prior radiation course
  • RiMO-301 injection to multiple lesions (≤ 5 in total) in a single patient is allowed as long as the total tumor volume does not exceed 250 cm3
  • Patient must have recovered from acute toxic effects (≤ grade 1 CTCAEv5) of previous cancer treatments prior to enrollment
  • Have adequate bone marrow reserve and adequate liver function
  • Have a life expectancy of at least 12 weeks
  • ECOG score of 0-2
  • Age 18 years or older

Exclusion Criteria:

  • Have signs or symptoms of end organ failure, major chronic illnesses other than cancer, or any severe concomitant conditions
  • Symptomatic central nervous system metastases and/or carcinomatous meningitis
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • Ongoing clinically significant infection at or near the incident lesion
  • Major surgery over the target area (excluding placement of vascular access) ≤21 days from beginning of the study drug or minor surgical procedures ≤7 days. No waiting is required following implantable port, enteral feeding tube and catheter placement
  • Has received any approved or investigational anti-neoplastic agent or immunotherapy other than PD-1 inhibitors (pembrolizumab or nivolumab) within 4 weeks prior to RiMO-301 injection
  • Patients with lesions which have significant blood vessel involvement (such as carotid artery encasement) or other major structures

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RiMO-301

Intratumoral injection of RiMO-301 followed by pembrolizumab or nivolumab followed by hypofractionated radiation

Interventions

RiMO-301

A single dose of RiMO-301 will be administered via an intratumoral injection.

PD-1 inhibitor (pembrolizumab or nivolumab) will be administered via a 30-minute intravenous infusion until disease progression or unacceptable toxicity.

Patients will receive hypofractionated radiation in 5 fractions.

Primary outcome measure

  • Determination of Recommended Dose [ Time Frame: 6 weeks ]
  • Evaluation of Anti-Tumor Response [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Ze-Qi Xu

630-415-5601zq@coordinationpharma.com

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Michelle Karan

312-996-9913makaran2@uic.edu

More Information

Sponsor

Coordination Pharmaceuticals, Inc.

Last update posted

Sep 17, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Coordination Pharmaceuticals, Inc. on 2025-09-17.