NCT05838729

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: Coordination Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives: * To determine the tolerability of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor (pembrolizumab or nivolumab) in patients with unresectable, recurrent or metastatic head-neck cancer * To determine the efficacy of RiMO-301 with hypofractionated X-ray radiotherapy and a PD-1 inhibitor (pembrolizumab or nivolumab) Secondary Objectives: * To evaluate progression-free survival for up to 12 months * To determine overall survival for up to 24 months * To assess patient quality of life The target population is patients with unresectable, recurrent or metastatic head-neck cancer which is clinically accessible to intratumoral injection.

Conditions

• Head Neck Cancer
• Intratumoral Injection

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2023-04-03
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2023-05-01
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study