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

NCT06182579 | Terminated Phase 1 FDA Drug

• 1 other identifier: RiMO-401CL23-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor; Intratumoral Injection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of Objective Response Rate (ORR)

  45 Days

• Evaluation of Safety and Tolerability

  45 Days

Other Outcomes (2)

• Evaluation of Maximum Plasma Concentration (Cmax)

  8 Days

• Evaluation of Area Under the Curve (AUC)

  8 Days

Study Arms (1)

RiMO-401

EXPERIMENTAL

• Single intratumoral injection followed by radiation

Drug: RiMO-401

Interventions

RiMO-401 DRUG

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

Also known as: Radiation

RiMO-401

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Coordination Pharmaceuticals, Inc.: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

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

Model Details: dose escalation in a 3+3 study design

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: December 27, 2023
• Study Start: February 22, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)