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

Launched by COORDINATION PHARMACEUTICALS, INC. · Dec 13, 2023

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ClinConnect Summary

This clinical trial is studying a new treatment called RiMO-401, which is given alongside radiation therapy for patients with advanced solid tumors. The goal is to find out the best dose of RiMO-401 that can be safely used in patients who have cancers that cannot be cured with standard treatments. In this study, RiMO-401 is injected directly into the tumor, and researchers will monitor how well it works and what the side effects are.

To participate, patients need to be 18 years or older and have advanced cancer that has not responded to standard therapies. They should have a tumor that can receive radiation and is suitable for injection. Participants will need to have a life expectancy of at least 12 weeks and have recovered from any recent treatments. It’s important to note that patients with certain types of blood cancers or significant health issues may not be eligible. Those who join the study will receive close medical supervision and support throughout the treatment process.

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Eligibility 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.