NCT06001684

Phase 1 Study of IBR854 in Locally Advanced Or Metastatic Solid Tumors

A Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR854 Cell Injection in Patients With Unresectable Locally Advanced Or Metastatic Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Imbioray (Hangzhou) Biomedicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of IBR854 cell injection in patients with unresectable, locally advanced, or metastatic solid tumors.

Detailed description

This study is a dose escalation study which adopts the 3+3 dose escalation design protocol. The dose is respectively 3.0×10\^9 cells, 5.0×10\^9 cells and 7.0×10\^9 cells. The administration is performed on day 1 and day 8 of each cycle (21 days). 3-6 subjects will be enrolled at every dose level. The first and second subjects in the same group shall be enrolled at an interval of at least 7 days, for the purpose of ensuring their safety. Only when the dose-limiting toxicity (DLT) of all subjects in the previous dose group was observed can the enrollment of the next dose group get started.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	IBR854 Cell Injection	The minimum initial dose is 3.0×10\^9 cells and then escalate to 5.0×10\^9 cells and 7.0×10\^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 8 of each cycle.

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-09-30
• Completion: 2024-12-30
• First posted: 2023-08-21
• Last updated: 2024-01-03

Locations

1 site across 1 country: China