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Study of RiMO-301 and Radiotherapy for Head-Neck Cancer

This study is looking at a new treatment approach for head-neck cancer that has returned, spread, or cannot be removed by surgery. It combines an experimental drug called RiMO-301, given as an injection into the tumor, with radiation therapy and a PD-1 inhibitor (like pembrolizumab or nivolumab). Researchers want to see how well this combination is tolerated and if it shrinks tumors. You could be eligible if you have head-neck cancer that needs palliative radiation and are already receiving or have progressed on certain chemotherapy treatments. The study aims to enroll 16 participants and is currently unclear about its recruitment status.

Study design
This is an open-label, single-arm study, meaning all participants receive the same treatment, and everyone knows what treatments are being given. It plans to enroll 16 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will evaluate anti-tumor response for up to 12 months, progression-free survival for up to 12 months, and overall survival for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05838729

Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer

Recruiting
PHASE1Ages 18+InterventionalTreatment
Coordination Pharmaceuticals, Inc.
~16 participants
Updated 2025-09-17 on ClinicalTrials.gov
What's tested:RiMO-301

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determination of Recommended Dose
Measured over 6 weeks
+1 more outcome measured

Conditions

Head Neck Cancer
Intratumoral Injection

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
Illinois1

Study leadership

  • Lawrence Feldman, MD · PRINCIPAL_INVESTIGATOR · University of Illinois at Chicago

Who to contact

Ze-Qi Xu
[email protected]
630-415-5601
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Determination of Recommended Dose6 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 Response12 months

    • To determine the objective response rate: complete or partial response, as defined by RECIST and itRECIST