Citius Pharmaceuticals has entered a clinical partnership with the University of Pittsburgh for a Phase I/Ib trial of I/ONTAK (denileukin diftitox or E7777) plus pembrolizumab to treat recurrent or metastatic solid tumours.
The open-label, investigator-initiated trial will assess T-reg cell depletion on administering I/ONTAK along with pembrolizumab in such patients.
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It will have two parts. The Part I dose escalation trial will have four cohorts assessing three, six, nine, and 12mcg doses of I/ONTAK and will enrol 18-30 subjects.
The Part II dose expansion trial will enrol nearly 40 subjects to assess the safety and tolerability of the recommended combination dosage of I/ONTAK plus pembrolizumab.
The trial will also evaluate the variation in the immune microenvironment within tumours, as well as in the peripheral blood.
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Objective response (complete response plus partial response), overall survival, and progression-free survival will be the trial’s secondary endpoints.
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By GlobalDataThe University of Pittsburgh trial is anticipated to commence in the fourth quarter of this year.
The company is also partnering with a Phase I investigator-initiated trial at the University of Minnesota (UMN).
This dose-finding trial is analysing I/ONTAK administered before tisagenleucel (KYMRIAH) CAR-T therapy in diffuse large B-cell lymphoma (DLBCL) patients.
The first patient in the study was enrolled in May last year.
A recombinant fusion protein, I/ONTAK merges the interleukin-2 (IL-2) receptor binding domain and diphtheria toxin fragments.
Pembrolizumab is a PD-1 checkpoint inhibitor.
Citius Pharmaceuticals chief medical officer Dr Myron Czuczman said: “Preclinical research in a syngeneic solid tumour mouse model shows that E7777 [denileukin diftitox] enhances anti-tumour activity and significantly extends the survival benefit of anti-PD-1 therapy.
“This data provides a positive signal of denileukin diftitox’s potential in the immuno-oncology space.”
In May this year, the company selected clinical research organisation Biorasi to aid in expanding its Phase III Mino-Lok trial of a new antibiotic lock therapy to further sites outside the US.
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