Citius Pharmaceuticals IncCTXRcollaborated with the University of Pittsburgh for I/ONTAK (denileukin diftitox or E7777) in combination with Merck & Company, Inc.MRK Keytruda (pembrolizumab) for recurrent or metastatic solid tumors.
The investigator-initiated trial at UPMC is an open-label, Phase 1/1b study consisting of two parts.
Part I is a dose escalation study of four cohorts and is expected to enroll 18-30 patients.
Part 2 is a dose expansion study of approximately 40 patients to evaluate the safety and tolerability of the recommended combination dose of I/ONTAK and pembrolizumab.
The study will also investigate the alteration of the immune microenvironment within tumors and peripheral blood.
Secondary endpoints include the objective response (complete response plus partial response), progression-free survival, and overall survival.
University of Pittsburgh dose-ranging study is expected to begin in the fourth quarter of 2022.
Additionally, Citius is collaborating with an investigator-initiated study at the University of Minnesota (UMN).
This Phase 1 dose-finding study to evaluate I/ONTAK before Novartis AG‘s NVS Kymriah (tisagenleucel) CAR-T therapy for diffuse large B-cell lymphoma (DLBCL) enrolled its first patient in May 2021.
Price Action: CTXR shares closed 6.84% higher at $1.25 during after-hours trading on Thursday.
