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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
Full description
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:
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:
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18 participants in 1 patient group
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Central trial contact
Ze-Qi Xu, Ph.D.
Data sourced from clinicaltrials.gov
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