NCT05838729 Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer
| NCT ID | NCT05838729 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Coordination Pharmaceuticals, Inc. |
| Condition | Head Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2023-04-03 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 16 participants in total. It began in 2023-04-03 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Lawrence Feldman, MD
PRINCIPAL INVESTIGATOR
University of Illinois at Chicago
Frequently Asked Questions
Who can join the NCT05838729 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05838729 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05838729 currently recruiting?
Yes, NCT05838729 is actively recruiting participants. Contact the research team at zq@coordinationpharma.com for enrollment information.
Where is the NCT05838729 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT05838729 clinical trial?
NCT05838729 is sponsored by Coordination Pharmaceuticals, Inc.. The principal investigator is Lawrence Feldman, MD at University of Illinois at Chicago. The trial plans to enroll 16 participants.
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