CLINICAL TRIAL / NCT03444714

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

Interventional
Recruiting
NCT03444714

Eligibility Details Visit Clinicaltrials.gov

Contact Information

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

This is a prospective, open-label, single arm, non-randomized study of RiMO-301 with radiation in patients with advanced tumors. A single escalation dose of RiMO-301 is intratumorally injected in a 3 + 3 study design to identify the recommended dose and dosing volumes. Condition or Disease: Patient with advanced tumor which is clinically accessible for intratumoral injection Intervention/Treatment: Drug - RiMO-301 Radiation - Radiotherapy Phase: Phase 1

Detailed Description

Primary Objectives: â€¢ The primary objective is to determine the maximum tolerated dose (MTD) of RiMO-301 as determined by toxicity observed in patients treated with palliative radiation doses Secondary Objectives: - To determine clinical response after RiMO-301 and radiotherapy as assessed by clinical response rate using clinical evaluation, imaging and/or symptom relief - To characterize adverse events of RiMO-301 in patients with advanced cancers - To evaluate the pharmacokinetics (PK) of RiMO-301 with radiation The target population is patients with clinically accessible lesions for intratumoral injection. Up to 3 dose levels (5%, 10%, and 15% of the total baseline tumor volume, respectively) will be tested in a 3 + 3 dose escalation study design. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intratumor injection of RiMO-301 to 30 days after the completion of radiation treatment: - Grade 4 or greater treatment related hematologic or dermatologic toxicity - Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (excluding nausea, vomiting or diarrhea without maximal medical intervention)

Eligibility Details

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers
No

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 (â‰¤ 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