RecruitingPhase 1Phase 2NCT05838729

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

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

Sponsor

Coordination Pharmaceuticals, Inc.

Enrollment

16 participants

Start Date

Apr 3, 2023

Study Type

INTERVENTIONAL

Conditions

Head & Neck Cancer Intratumoral Injection

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests RiMO-301, a drug that makes tumors more sensitive to radiation, combined with palliative (symptom-relieving) radiation and an immunotherapy drug (anti-PD-1 inhibitor) for people with head and neck cancer that has returned or spread and cannot be surgically removed. **You may be eligible if...** - You have head and neck squamous cell carcinoma (HNSCC) that is unresectable, recurrent, or metastatic - You need palliative radiation therapy - You are currently receiving or are eligible to receive an immune checkpoint inhibitor (pembrolizumab or nivolumab) - You are in adequate general health **You may NOT be eligible if...** - Your cancer can be treated with curative intent (surgery or definitive chemoradiation) - You have serious autoimmune disease or recent organ transplant - You are pregnant or breastfeeding - Prior radiation to the target area limits further treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRiMO-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.