ONCT-534 is intended for the treatment of metastatic castration-resistant prostate cancer. Credit: Nemes Laszlo/Shutterstock.com.

Oncternal Therapeutics has dosed the first patient in the Phase I/II ONCT-534-101 study of ONCT-534 to treat metastatic castration-resistant prostate cancer (mCRPC).

The dose escalation/dose expansion, multi-centre, open-label, single-arm study is designed to assess the pharmacokinetics, tolerability, safety and anti-tumour activity of the dual-action androgen receptor inhibitor ONCT-534.

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mCRPC patients who have relapsed or are refractory to androgen receptor signalling inhibitors (ARSIs) such as apalutamide, darolutamide, abiraterone and enzalutamide are included in the study.

The recommended Phase 2 dose (RP2D) will be determined in the Phase I portion and will be used in the Phase II study to further validate the dose and assess the efficacy and safety of ONCT-534.

Oncternal chief medical officer Salim Yazji said: “Preclinical studies suggest that ONCT-534 may address important tumour escape mechanisms that result in resistance to currently available AR inhibitors, such as enzalutamide or abiraterone.

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“We intend to advance the dose escalation portion of the Phase I/II Study ONCT-534-101 quickly, and we will be enrolling patients in sites across the US over the coming weeks and in the United Kingdom in early 2024.

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“We expect to report initial clinical data in the first half of 2024.”

ONCT-534 inhibits cell growth and induces AR degradation by interacting with both the N-terminal and the ligand-binding domains of the androgen receptor.

The company’s product portfolio also includes the autologous chimeric antigen receptor T cell therapy ONCT-808 for the treatment of several solid tumours and haematological malignancies.