Status:
TERMINATED
Phase I Study of RiMO-401 With Radiation in Advanced Tumors
Lead Sponsor:
Coordination Pharmaceuticals, Inc.
Conditions:
Advanced Solid Tumor
Intratumoral Injection
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 recommende...
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 r...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06182579
Start Date
February 22 2024
End Date
June 16 2025
Last Update
September 17 2025
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612