Using RiMO-401 with radiation for advanced tumors
Phase I Dose-Escalation Study of RiMO-401 With Radiation in Advanced Tumors
PHASE1 · Coordination Pharmaceuticals, Inc. · NCT06182579
This study is testing a new treatment called RiMO-401 combined with radiation to see if it helps people with advanced tumors feel better and tolerate the treatment well.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Coordination Pharmaceuticals, Inc. (industry) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06182579 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and tolerability of RiMO-401 when combined with palliative radiation therapy in patients with advanced solid tumors. It employs a single-arm, dose-escalation design to identify the optimal dose of RiMO-401 through intratumoral injection. The study also aims to assess the clinical response and adverse events associated with this treatment approach, as well as the pharmacokinetics of RiMO-401. Patients with accessible lesions suitable for palliative radiation are the focus of this investigation.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced or metastatic cancer that is not amenable to curative therapy and has lesions suitable for palliative radiation.
Not a fit: Patients with tumors that have been previously irradiated within the last six months or those who do not have accessible lesions for injection 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 who have limited treatment alternatives.
How similar studies have performed: While this approach is novel, similar studies combining targeted therapies with radiation have shown promise in other contexts.
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 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.
Where this trial is running
Chicago, Illinois
- University of Illinois at Chicago — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Study coordinator: Ze-Qi Xu, Ph.D.
- Email: ZQ@COORDINATIONPHARMA.COM
- Phone: 630-415-5601
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.
Conditions: Advanced Solid Tumor, Intratumoral Injection