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Amplia Therapeutics to Start Phase 2B Study of Pancreatic Cancer Drug Candidate

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Amplia Therapeutics (ASX:ATX) is initiating a phase 2b study of its narmafotinib drug candidate in combination with chemotherapies gemcitabine and Abraxane in newly diagnosed advanced pancreatic cancer patients to explore a new dosing regimen, according to a Tuesday Australian bourse filing.

Each dosing group will have six patients, which will be combined with gemcitabine and Abraxane given on their conventional schedule, the filing said. The study will assess safety and tolerability, pharmacokinetics, and efficacy. Exploratory endpoints will include effects on disease biomarkers as well as effects on fibrosis.

The study, designed in alignment with US Food and Drug Administration feedback, will enroll patients across three to four sites in Australia starting in the fourth quarter, per the filing. It will form the first stage of a registrational study in this indication.

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