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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Coordination Pharmaceuticals, Inc.
Study ID
NCT05838729
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Head Neck Cancer
  • Intratumoral Injection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RiMO-301 — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 3, 2023
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RiMO-301
    Intratumoral injection of RiMO-301 followed by pembrolizumab or nivolumab followed by hypofractionated radiation

Primary Outcome Measure

Determination of Recommended Dose [ Time Frame: 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois at ChicagoChicagoIllinois60612
Michelle Karan
312-996-9913

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