Using RiMO-301 with radiation to treat advanced tumors
Phase I Dose-Escalating Study of RiMO-301 With Radiation in Advanced Tumors
This study is testing a new treatment called RiMO-301 combined with radiation to see if it can help people with advanced tumors feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Coordination Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT03444714 on ClinicalTrials.gov |
What this trial studies
This is a Phase I clinical trial evaluating the safety and maximum tolerated dose of RiMO-301 when administered intratumorally alongside palliative radiation therapy in patients with advanced tumors. The study employs a 3 + 3 dose escalation design to identify the optimal dose while monitoring for adverse effects. Secondary objectives include assessing clinical response rates and pharmacokinetics of RiMO-301 in conjunction with radiation treatment. The trial focuses on patients with accessible lesions suitable for this combined approach.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with advanced or metastatic cancer that has accessible lesions for intratumoral injection and is suitable for palliative radiation.
Not a fit: Patients with lymphomas or leukemias, or those who have recently undergone certain cancer treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced tumors that are not amenable to curative therapies.
How similar studies have performed: While this approach is novel in its specific combination, similar studies using intratumoral therapies have shown promise in treating various cancers.
Eligibility criteria
Show full inclusion / exclusion 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 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 Criteria: * 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
Where this trial is running
Chicago, Illinois and 1 other locations
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Ze-Qi Xu, Ph.D.
- Email: zq@coordinationpharma.com
- Phone: 6304155601
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.