NCT06346041

Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors

A Phase I Study of Evaluating the Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 19 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD or MFD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of IDOV-SAFETM in patients with advanced solid tumors.

Detailed description

The study is a single agent dose escalation which will use an accelerated and "3+3" design to evaluate escalating doses of IDOV-SAFETM.Total enrollment will depend on the toxicities and/or activity observed, with approximately 13-19 evaluable participants enrolled. A Dose-Limiting Toxicity (DLT) observation period of 3weeks was established before the entry of the first patient at the next dose level. After all subjects in the current dose group have completed the DLT observation period, the administration of the next dose group can only be started if the condition of dose escalation is met.

Conditions

• Neoplasms

Interventions

Type	Name	Description
BIOLOGICAL	Oncolytic Virus injection(IDOV-SAFETM)	Administered by intravenous injection as single agent.

Timeline

• Start date: 2024-04-12
• Primary completion: 2025-12-31
• Completion: 2026-04-01
• First posted: 2024-04-03
• Last updated: 2025-02-04

Locations

1 site across 1 country: China