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

NCT ID: NCT06182579

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-22
• Study Completion Date: 2025-06-16

Brief Summary

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.

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.

Conditions

Advanced Solid Tumor; Intratumoral Injection

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RiMO-401

• Single intratumoral injection followed by radiation

Group Type: EXPERIMENTAL

RiMO-401

Intervention Type: DRUG

• Single intratumoral injection of RiMO-401 followed by palliative radiotherapy

Interventions

RiMO-401

• Single intratumoral injection of RiMO-401 followed by palliative radiotherapy

Intervention Type: DRUG

Other Intervention Names

Radiation

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Coordination Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

RiMO-401CL23-001

Identifier Type: -

Identifier Source: org_study_id