Clinical Trial TitleA phase I dose-escalating study of RiMO-301 with radiation in advanced tumors.
National Clinical Trial Number:NCT03444714
Clinical Trial Protocol Description:
The purpose of this study is to determine the safety and side effects of the study drug, RiMO-301. RiMO-301 is an investigational drug, which means that it has not been approved by the U.S. Food and Drug Administration (FDA) and must be tested to see if it is a safe and effective treatment method for the disease or condition being studied. RiMO-301 is made from nanoparticle technology, intended to make radiation therapy more effective in killing cancer cells for solid tumors.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have a diagnosis of advanced or metastatic solid tumor not amenable to curative therapy.
- Have a lesion that is amenable to palliative radiotherapy.
- Have a lesion that is technically feasible to irradiation and accessible for direct intratumoral injection of nanoparticles.
- Have a target tumor in region not in previously irradiated field.
- Have recovered from acute toxic effects (≤ grade 1 CTCAEv4) of previous cancer treatments prior to enrollment.
- Are at least 18 years of age.
- Have measurable disease, defined as at least 1 tumor that fulfills the criteria for a target lesion according to RECIST 1.1. Tumors may be from 1 cm to 6 cm in size and volume is ≤ 100 cm3
- Prior treatments for metastatic disease are permitted but may not be ongoing.
- The recurrence or second primary must have defined bi- or uni-dimensional measurements.
- Treatment of multiple lesions in a single patient is allowed as long as the total tumor volume does not exceed 100 cm3 and no more than 3 lesions treated in a single patient.
- No clinical suspicion of synchronous brain metastasis. If a history of brain metastasis or if clinical symptoms warrant, brain imaging within 3 months of study enrollment.
- Females with child bearing age should be using adequate contraceptive measures from the time of screening until 6 months after study discontinuation, should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
- Sign a study-specific informed consent form prior to study entry.
This is a partial list of elgibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.