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

NCT03444714 | Completed Phase 1 FDA Drug

• 1 other identifier: RiMO-CL17-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Advanced Tumors

Keywords

intratumoral

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• clinical benefit

  45 days

• adverse effect

  45 days

• Maximum Plasma Concentration [Cmax]

  45 days

• Area Under the Curve [AUC]

  45 days

Study Arms (1)

RiMO-301+Radiotherapy

EXPERIMENTAL

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

Interventions

RiMO-301 DRUG

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

Also known as: Radiotherapy

RiMO-301+Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Coordination Pharmaceuticals, Inc.: lead
• University of Chicago: collaborator

Study Sites (2)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 + 3 dose escalation study design

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: February 23, 2018
• Study Start: April 10, 2018
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)