Phase I Study of RiMO-401 With Radiation in Advanced Tumors

Phase I Dose-Escalation Study of RiMO-401 With Radiation in Advanced Tumors

This is a single arm study of RiMO-401 with radiation in patients with advanced tumors. A single escalation dose of RiMO-401 is intratumorally injected in a 3+3 study design to identify the recommended dose.

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumor; Intratumoral Injection
• Intervention / Treatment: Drug: RiMO-401

Detailed Description

Primary Objectives:

• To determine the tolerability of RiMO-401 with palliative radiation as assessed by CTCAEv5

Secondary Objectives:

• To determine clinical response of RiMO-401 with palliative radiotherapy
• To characterize adverse events of RiMO-401 in patients with advanced cancers
• To characterize the pharmacokinetics of RiMO-401 with palliative radiation

The target population comprises patients with clinically accessible lesions that can be trated with palliative radiation.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Diagnosis of advanced or metastatic cancer not amenable to curative therapy
• Lesion that is amenable to palliative radiotherapy
• Lesion that is technically feasible for intratumoral injection
• Target tumor in region not in the field that was irradiated within the past six months
• Patients with advanced or metastatic HNSCC must have progressed on or been intolerant to standard of care therapies including platinum-based chemotherapy and anti-PD(L)1 therapy, prior to study enrollment
• Patient must have recovered from acute toxic effects (≤ grade 1) of previous cancer treatments prior to enrollment
• Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion
• ECOG score of 0-1
• Have a life expectancy of at least 12 weeks
• Have adequate bone marrow reserve and adequate liver function
• Both males and females and their partners of childbearing potential must agree to use adequate contraceptive measures
• Patients must sign a study-specific informed consent form prior to study entry
• Age 18 years or older.

Exclusion Criteria:

• Patients with a histological diagnosis of lymphomas and/or leukemias
• Patients with significant blood vessels (such as carotid artery encasement) or other major structures in the tumor region to be injected
• Patients may not have received chemotherapy, targeted therapies, immunotherapies, biologic response modifiers and/or hormonal therapy within the last 14 days
• 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
• Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that would make the patient inappropriate for enrollment in this study
• Has any mental or medical condition that prevents the patient from giving informed consent or participating in the trial
• Pregnant and nursing women
• Patients with a target lesion located in a previously irradiated field
• Patients with a target lesion in the field that had complications from prior radiotherapy that are not amenable to repeat irradiation.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RiMO-401; • Single intratumoral injection followed by radiation	Drug: RiMO-401; • Single intratumoral injection of RiMO-401 followed by palliative radiotherapy; Other Names: Radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of Recommended Dose	The dose limiting toxicities of RiMO-401 with palliative radiation, as assessed by CTCAEv5, will not be observed in 33% or more patients	45 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Objective Response Rate (ORR)	The Objective Response Rate (ORR) will be determined by imaging according to RECIST 1.1	45 Days
Evaluation of Safety and Tolerability	Incidence and severity of clinical and laboratory adverse events will be assessed according to CTCAEv5	45 Days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Maximum Plasma Concentration (Cmax)	Plasma concentrations of RiMO-401 will be measured until 8 days after administration	8 Days
Evaluation of Area Under the Curve (AUC)	Plasma concentrations of RiMO-401 will be measured until 8 days after administration	8 Days

Collaborators and Investigators

• Sponsor: Coordination Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 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: Physical Phenomena; Radiation
• Other Study ID Numbers: RiMO-401CL23-001

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