Histopathology of gastric adenocarcinoma representing a signet ring cell variant. Credit: KGH.

Bio-Thera Solutions has submitted an investigational new drug application (IND) to China National Medical Products Administration (NMPA) to begin a Phase I clinical trial assessing BAT8003 as a therapeutic agent for the treatment of Trop2 positive cancers.

BAT8003 is an investigational anti-Trop2 antibody-drug conjugate (ADC) that could be used to treat a variety of tumour types.

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Once approved, the planned trial is expected to commence early this year.

Bio-Thera Solutions CEO Dr Shengfeng Li said: “Pending NMPA acceptance of the IND, we will begin the dose escalation portion of this Phase I trial early in 2019 and anticipate reporting on the early safety assessment and determination of a maximum tolerated dose in mid-year 2019.”

“We will begin the dose escalation portion of this Phase I trial early in 2019 and anticipate reporting on the early safety assessment in mid-year 2019.”

The Phase I trial aims to investigate the safety, tolerability and pharmacokinetics of BAT8003 as a single agent in patients with Trop2 positive cancers.

The first group of patients will be enrolled in a standard dose escalation regimen to establish the safety, pharmacokinetics and maximum tolerated dose of BAT8003.

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Bio-Thera intends to study multiple dose expansion cohorts with patients suffering from Trop2 positive cancers including triple negative breast and gastric cancers.

The primary goal of the dose expansion cohort is to confirm the safety and clinical activity of BAT8003.

Trop2 is also called tumour-associated calcium signal transducer 2 and trophoblast cell surface antigen 2. It is a transmembrane glycoprotein that serves as an intracellular calcium signal transducer.