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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03444714.
Primary Objectives:
• 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)
Lead OrganizationCoordination Pharmaceuticals, Inc.
