Phase I Study of RiMO-301 With Radiation in Advanced Tumors

Phase I Dose-Escalating Study of RiMO-301 With Radiation in Advanced Tumors

This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with radiation in patients with advanced tumors. A single escalation dose of RiMO-301 is intratumorally injected in a 3 + 3 study design to identify the recommended dose and dosing volumes.

Condition or Disease:

Patient with advanced tumor which is clinically accessible for intratumoral injection

Intervention/Treatment:

Drug - RiMO-301

Radiation - Radiotherapy

Phase:

Phase 1

Study Overview

• Status: Completed
• Conditions: Advanced Tumors
• Intervention / Treatment: Drug: RiMO-301

Detailed Description

Primary Objectives:

• The primary objective is to determine the maximum tolerated dose (MTD) of RiMO-301 as determined by toxicity observed in patients treated with palliative radiation doses

Secondary Objectives:

• To determine clinical response after RiMO-301 and radiotherapy as assessed by clinical response rate using clinical evaluation, imaging and/or symptom relief
• To characterize adverse events of RiMO-301 in patients with advanced cancers
• To evaluate the pharmacokinetics (PK) of RiMO-301 with radiation

The target population is patients with clinically accessible lesions for intratumoral injection. Up to 3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study design. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intratumor injection of RiMO-301 to 30 days after the completion of radiation treatment:

• Grade 4 or greater treatment related hematologic or dermatologic toxicity
• Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (excluding nausea, vomiting or diarrhea without maximal medical intervention)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (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 to irradiation and accessible for direct intratumoral injection
• Target tumor in region not in previously irradiated field
• Patient must have recovered from acute toxic effects (≤ grade 1) of previous cancer treatments prior to enrollment
• Age >18 years
• Has measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion
• Females with child bearing age should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to the start of dosing
• Patients must sign a study-specific informed consent form prior to study entry

Exclusion Criteria:

• Patients with a histological diagnosis of lymphomas and/or leukemias
• Patients may not have received chemotherapy, targeted therapies, 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

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+Radiotherapy; 3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study	Drug: RiMO-301; Drug: RiMO-301 RiMO-301 will be administered by intratumoral route as slow injection Radiotherapy Patients will receive 10 fractions of 3 Gy each over 2 weeks; Other Names: Radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Tolerated Dose (MTD)	• To determine the maximum tolerated dose (MTD), which is defined as the dose level at which fewer than 33% of patients experience a dose limiting toxicity (DLT) using a 3+3 strategy	45 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical benefit	• To assess clinical benefit by change in tumor size and resolution of symptoms, which will be reported as response rate (%)	45 days
adverse effect	• To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE	45 days
Maximum Plasma Concentration [Cmax]	• To evaluate Maximum Plasma Concentration [Cmax] of RiMO-301 in patients tested	45 days
Area Under the Curve [AUC]	To evaluate Area Under the Curve [AUC] of RiMO-301 in patients tested	45 days

Collaborators and Investigators

• Sponsor: Coordination Pharmaceuticals, Inc.
• Collaborators: University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2018
• Primary Completion (Actual): June 16, 2025
• Study Completion (Actual): June 16, 2025

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: February 19, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: intratumoral
• Additional Relevant MeSH Terms: Therapeutics; Radiotherapy
• Other Study ID Numbers: RiMO-CL17-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will not be shared due to confidentiality agreements

Drug and device information, study documents

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