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Be Part of Research - Trial Details - A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.

A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.

Stopped

Open to: MALE

Age: 18.0 - N/A

Medical Conditions

Prostatic Neoplasms


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


A first-in-human clinical trial to test the investigational treatment ONCT-534 in participants with metastatic castration-resistant prostate cancer. The main questions it aims to answer are:

* What are the most tolerable doses of ONCT-534? (Phase 1) * Does ONCT-534 have anti-tumor activity at tolerable doses? (Phase 2)

This is a dose escalation and expansion study where participants will receive daily oral doses of ONCT-534.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Sep 2023 Sep 2024

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : ONCT-534 is a dual-action androgen receptor inhibitor (DAARI) with a novel mechanism of action that includes inhibition of AR function and degradation of the AR protein mediated by interaction with the N-terminal domain (NTD) of the AR. ONCT-534 has demonstrated preclinical activity in prostate cancer models against both unmutated androgen receptor (AR), and against multiple forms of AR alteration, including those with AR amplification, mutations in the AR ligand binding domain (LBD), and splice variants with loss of the AR LBD.

Intervention Arm Group : BID Dose Level 1: 160 mg BID;BID Dose Level 2: 300 mg BID;Dose Level 1: 40mg QD;Dose Level 2: 80mg QD;Dose Level 3: 160mg QD;Dose Level 4: 300mg QD;Dose Level 5: 600mg QD;Dose Level 6: 1200 mg QD;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden NHS Trust
    Sutton
    Surrey
    SM2 5PT


The study is sponsored by Oncternal Therapeutics, Inc





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Read full details for Trial ID: NCT05917470
Last updated 09 December 2024

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