NCT01905228

A Phase 1 Trial of CBL0137 in Patients With Metastatic or Unresectable Advanced Solid Neoplasm

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Incuron · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multi-center, sequential groups, dose-escalation study of CBL0137 administered intravenously in participants with metastatic or unresectable advanced solid malignancies.

Detailed description

The primary objective of the study is to determine the maximally tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of CBL0137. The secondary objectives are to describe the dose-limiting toxicity (DLT) and adverse event profile of CBL0137, to describe the pharmacokinetic profile of CBL0137, to document any objective responses to CBL0137. This is a study of CBL0137 with a standard "3+3" design. Escalation will proceed to the MTD based on DLT in the 1st cycle in 1 of 6 participants in a cohort.

Conditions

• Solid Tumors
• Glioblastoma

Interventions

Type	Name	Description
DRUG	CBL0137	All doses are administered intravenously on Days 1, 8 and 15 of every 28 day cycle. Number of Cycles: 2 or until progression or unacceptable toxicity develops

Timeline

• Start date: 2013-07-01
• Primary completion: 2019-05-01
• Completion: 2019-06-01
• First posted: 2013-07-23
• Last updated: 2020-12-10

Locations

4 sites across 1 country: United States