NCT06182579

Phase I Study of RiMO-401 With Radiation in Advanced Tumors

Phase I Dose-Escalation Study of RiMO-401 With Radiation in Advanced Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Coordination Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm study of RiMO-401 with radiation in patients with advanced tumors. A single escalation dose of RiMO-401 is intratumorally injected in a 3+3 study design to identify the recommended dose.

Detailed description

Primary Objectives: • To determine the tolerability of RiMO-401 with palliative radiation as assessed by CTCAEv5 Secondary Objectives: * To determine clinical response of RiMO-401 with palliative radiotherapy * To characterize adverse events of RiMO-401 in patients with advanced cancers * To characterize the pharmacokinetics of RiMO-401 with palliative radiation The target population comprises patients with clinically accessible lesions that can be trated with palliative radiation.

Conditions

• Advanced Solid Tumor
• Intratumoral Injection

Interventions

Type	Name	Description
DRUG	RiMO-401	• Single intratumoral injection of RiMO-401 followed by palliative radiotherapy

Timeline

• Start date: 2024-02-22
• Primary completion: 2025-06-16
• Completion: 2025-06-16
• First posted: 2023-12-27
• Last updated: 2025-09-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study