Phase I Study of RiMO-301 With Radiation in Advanced Tumors

Launched by COORDINATION PHARMACEUTICALS, INC. · Feb 19, 2018

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called RiMO-301 combined with radiation therapy for patients with advanced tumors that cannot be cured with standard treatments. The goal is to find the best dose of RiMO-301 that can be safely injected directly into the tumor. This study is open to adults over 18 who have a specific type of advanced cancer and have a tumor that can be treated with radiation. Participants should have recovered from any recent cancer treatments and must not have any other major health issues that could complicate their participation.

If you choose to participate, you will receive RiMO-301 injected into your tumor along with radiation therapy. The study is currently looking for volunteers and aims to ensure that the treatment is safe and effective. Before enrolling, you will need to sign a consent form and may have to meet certain health criteria. It's important to note that patients with certain types of cancer, recent treatments, or significant health problems may not be eligible for this study.

Gender

ALL

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 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