Bio-Path Holdings has completed the first cohort of the dose escalation portion of its Phase I/Ib trial of BP1001-A (liposomal Grb2) for the treatment of patients with solid tumours.
The trial initially enrolled a total of nine patients who will receive BP1001-A alone in a standard 3+3 design.
Three patients from the first cohort, including one patient with hepatic lesions and two with advanced gynaecologic lesions, will receive BP1001-A 60mg/m².
Patients who were previously treated with chemotherapies and/or surgeries for their disease were selected and enrolled at three different centres.
The remaining six patients will receive BP1001-A alone at doses of 90mg/m² and 135mg/m².
All patients in the first cohort will receive two doses per week over four weeks, resulting in eight doses administered over 28 days.
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The company anticipates initiating the Phase Ib portion after the completion of the BP1001-A monotherapy cohorts.
It intends to evaluate the efficacy and safety of BP1001-A, along with paclitaxel, in patients with recurrent ovarian or endometrial tumours, and with gemcitabine in patients with metastatic pancreatic tumours.
Bio-Path Holdings president and CEO Peter Nielsen said: “We are delighted to have completed the first cohort of this first-in-human Phase I/Ib study of BP1001-A as it further demonstrated the drug’s favourable safety profile, which is critical for the treatment of these very vulnerable cancer patients.
“Importantly, this achievement enables us to advance to the second cohort of this important study in solid tumour cancers, for which we hope to complete enrolment by year-end 2023.”
The dose escalation portion of the trial is underway at more than eight cancer centres in the US, including the Karmanos Cancer Center, the Mary Crowley Cancer Research Center, and the University of Texas MD Anderson Cancer Center.