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A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer. - Trial NCT05917470

Access comprehensive clinical trial information for NCT05917470 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by Oncternal Therapeutics, Inc and is currently Not yet recruiting. The study focuses on Metastatic Castration-resistant Prostate Cancer. Target enrollment is 59 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05917470
Phase 1/2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05917470
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A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer.
A Phase 1/2 Study of ONCT-534 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Study Focus

ONCT-534

Interventional

drug

Sponsor & Location

Oncternal Therapeutics, Inc

Timeline & Enrollment

Phase 1/2

Sep 30, 2023

Jan 31, 2028

59 participants

Primary Outcome

Determination of the MTD of ONCT-534,Assess safety and tolerability of ONCT-534,Reduction of PSA by more than 50%,Time to reduction of PSA by more than 50%,Reduction of PSA by more than 90%,Time to reduction of PSA by more than 90%,Objective Response Rate,Complete Response Rate,Duration of Response,Progression Free Survival

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.

ICD-10 Classifications

Malignant neoplasm of prostate
Hyperplasia of prostate
Carcinoma in situ: Prostate
Special screening examination for neoplasm of prostate
Dysplasia of prostate

Data Source

ClinicalTrials.gov

NCT05917470

Non-Device Trial