Life sciences company CBT Pharmaceuticals has begun patient enrolment in Phase I clinical trial of genolimzumab (CBT-501) for the treatment of advanced solid tumours in Australia.

Genolimzumab is a new humanised IgG4 monoclonal antibody being developed to target the programmed death-1 (PD-1) membrane receptor on cells of the immune system such as T-lymphocytes.

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The multi-centre, open-label trial is designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of genolimzumab in up to 50 patients with recurrent or refractory advanced solid tumours.

The two part, three cohort trial will include a dose escalation segment with 3+3 design, as well as a dose and disease expansion segment.

"The trial will determine a recommended dose for future Phase II trial and will establish dose limiting toxicities or a biologically relevant dose."

CBT Pharmaceuticals president and chief executive officer Sanjeev Redkar said: “The dosing of our first subject with genolimzumab is a significant milestone for the company and we are very pleased to begin the development of this important second generation PD-1 drug candidate intended to treat patients with cancer.

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“In the clinic, we hope to define the unique characteristics of this agent shown pre-clinically, and ultimately, differentiating it in a combination approach with other targeted agents, standard marketed therapies, and other immune-oncology agents.”

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Patients with select type of tumours such as colorectal, head and neck, gastric including gastroesophageal junction adenocarcinoma, hepatocellular, endometrial, non-small-cell lung cancer, ovarian, mesothelioma, and renal-cell carcinoma will be recruited.

The trial will determine a recommended dose for future Phase II trial and will establish dose limiting toxicities or a biologically relevant dose.

The preliminary efficacy and progression free survival will be assessed for two or more select tumours following the dose and schedule determination.