Actively Recruiting
Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer
Led by Coordination Pharmaceuticals, Inc. · Updated on 2025-09-17
16
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
C
Coordination Pharmaceuticals, Inc.
Lead Sponsor
U
University of Illinois at Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of RiMO-301 and Radiotherapy With PD-1 Inhibitor for the Treatment of Head-Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of head-neck cancer requiring palliative radiotherapy
- Unresectable, recurrent or metastatic head and neck squamous cell carcinoma
- Receiving or suitable to receive PD-1 inhibitor (pembrolizumab or nivolumab) as standard care
- At least one measurable tumor accessible for RiMO-301 injection and radiation treatment
- Target tumor not previously irradiated within 6 months or causing complications from prior radiation
- RiMO-301 injection allowed to up to 5 lesions if total tumor volume ≤ 250 cm3
- Recovered from acute toxic effects (≤ grade 1 CTCAEv5) of previous cancer treatments
- Adequate bone marrow and liver function
- Life expectancy of at least 12 weeks
- ECOG performance status 0-2
- Age 18 years or older
You will not qualify if you...
- Signs or symptoms of end organ failure or major chronic illnesses other than cancer
- Symptomatic central nervous system metastases or carcinomatous meningitis
- Active autoimmune disease requiring systemic treatment in past 2 years
- Ongoing significant infection at or near the tumor site
- Major surgery over target area within 21 days or minor surgery within 7 days before study drug
- Received anti-cancer or immunotherapy other than PD-1 inhibitors within 4 weeks before RiMO-301
- Tumors with significant blood vessel involvement or major structure involvement
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
Research Team
Z
Ze-Qi Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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