US-based clinical-stage biopharmaceutical firm Tracon Pharmaceuticals has started dosing patients in the Phase I/II clinical trial of TRC253 for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

Discovered by Janssen research and development, TRC253 is an orally bioavailable, small molecule inhibitor of androgen receptor (AR) and AR mutations such as F876L, which modify the AR ligand binding, known to cause resistance to prostate cancer therapies.

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Tracon licensed the drug from Janssen last September.

The multi-centre, open-label, two-part Phase I/II trial will assess the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of TRC253 in dose escalation and dose expansion parts.

"The multi-centre, open-label, two-part Phase I/II trial will assess the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of TRC253 in dose escalation and dose expansion parts."

Tracon Pharmaceuticals president and CEO Charles Theuer said: “I am proud of the efforts of the Tracon team who made it possible for us to quickly file the IND, open multiple sites and dose TRC253 in a Phase I/II trial following the establishment of our strategic licensing collaboration with Janssen.

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"We think TRC253 has the potential to be a best-in-class androgen receptor antagonist, and address an unmet medical need in the treatment of men with metastatic castration-resistant prostate cancer who develop resistance to androgen receptor inhibitors.”

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The safety, recommended dose for Phase II and evaluation of response using prostate-specific antigen (PSA) levels will be measured as the primary objectives of the trial.

The trial’s Phase II portion will include circulating tumour DNA testing to allow biomarker-directed therapy for patients who have progressed after treatment with an AR inhibitor.