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

Advanced Tumors Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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:

• 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) ;

Related Conditions & MeSH terms

• Advanced Tumors

• NCT number: NCT03444714
• Study type: Interventional
• Source: Coordination Pharmaceuticals, Inc.
• Contact: Ze-Qi Xu, Ph.D.
• Phone: 6304155601
• Email: zq@coordinationpharma.com
• Status: Recruiting
• Phase: Phase 1
• Start date: April 10, 2018
• Completion date: December 2024