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

NCT05917470 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-12-11

Study results available
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Summary

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.

Conditions

Interventions

DRUG

ONCT-534

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.

Sponsors & Collaborators

  • Oncternal Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Salim Yazji, MD · Oncternal Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-20
Primary Completion
2024-09-12
Completion
2024-09-12
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05917470 on ClinicalTrials.gov