Status:
COMPLETED
Phase I Study of RiMO-301 With Radiation in Advanced Tumors
Lead Sponsor:
Coordination Pharmaceuticals, Inc.
Collaborating Sponsors:
University of Chicago
Conditions:
Advanced Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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 Second...
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 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
- 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
Key Trial Info
Start Date :
April 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03444714
Start Date
April 10 2018
End Date
June 16 2025
Last Update
September 15 2025
Active Locations (2)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
2
University of Chicago Medical Center
Chicago, Illinois, United States, 60637