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Clinical Trial Summary

This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single intratumoral (IT) injection of C5252 in patients with recurrent or progressive glioblastoma (GBM).


Clinical Trial Description

This is a Phase 1 open label, first in human study of C5252 monotherapy designed to determine the safety and tolerability of a single IT injection of C5252 in patients with recurrent or progressive GBM. The Part 1 portion of the study is a 3+3 design to evaluate escalating doses of C5252. Total enrollment will depend on the toxicities and/or activity observed, with approximately 36 evaluable participants enrolled. Once the recommended dose (RD) is identified from Part 1, Part 2 Dose Expansion will enroll up to 15 additional participants to further assess the safety, tolerability, and preliminary efficacy of a single IT injection of C5252 monotherapy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05095441
Study type Interventional
Source ImmVira Pharma Co. Ltd
Contact ImmVira Pharma Co., LTD
Phone 781-718-5121
Email clinicaltrials@immviragroup.com
Status Not yet recruiting
Phase Phase 1
Start date March 15, 2023
Completion date April 30, 2026

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