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

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.

Study Overview

• Status: Recruiting
• Conditions: Head Neck Cancer; Intratumoral Injection
• Intervention / Treatment: Drug: RiMO-301

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Ze-Qi Xu; Phone Number: 630-415-5601; Email: zq@coordinationpharma.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois at Chicago
      • Contact: Michelle Karan; Phone Number: 312-996-9913; Email: makaran2@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RiMO-301; Intratumoral injection of RiMO-301 followed by pembrolizumab or nivolumab followed by hypofractionated radiation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Recommended Dose	• 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	6 weeks
Evaluation of Anti-Tumor Response	• To determine the objective response rate: complete or partial response, as defined by RECIST and itRECIST	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Progression-Free Survival	Time from enrollment to local-regional recurrence, local-regional progression, distant progression or death from any cause, whichever occurs first	12 months
Evaluation of Overall Survival	Time from enrollment to death from any cause	24 months

Collaborators and Investigators

• Sponsor: Coordination Pharmaceuticals, Inc.
• Collaborators: University of Illinois at Chicago
• Investigators: Principal Investigator: Lawrence Feldman, MD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nivolumab; Pembrolizumab; Immune Checkpoint Inhibitors
• Other Study ID Numbers: RiMO-HNC-IO1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No