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ONCT-534 for Prostate Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Oncternal Therapeutics, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 108 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new treatment for prostate cancer to find safe doses and if it has anti-tumor activity. It involves daily doses of the investigational drug ONCT-534.

Who is the study for?
This trial is for men over 18 with metastatic castration-resistant prostate cancer that has progressed after treatment. They must have good kidney, liver, and lung function, a specific type of prostate cancer without certain features, and at least one measurable lesion or evaluable bone disease. Participants need to maintain hormone therapy or be surgically sterile and use contraception.
What is being tested?
ONCT-534 is being tested in this study to find the safest doses (Phase 1) and check if it can shrink tumors (Phase 2). Patients will take ONCT-534 daily by mouth. The study gradually increases doses to determine safety before assessing its effectiveness against tumors.
What are the potential side effects?
While the side effects of ONCT-534 are not detailed here as it's a first-in-human trial, common side effects from similar treatments may include nausea, fatigue, diarrhea, skin reactions, hormonal changes affecting mood or energy levels.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~108 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 108 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess safety and tolerability of ONCT-534
Complete Response Rate
Determination of the MTD of ONCT-534
+7 more
Secondary study objectives
Assess Area Under the Curve (AUC) of ONCT-534
Assess Maximum Plasma Concentration (Cmax) of ONCT-534
Correlate anti-tumor activity of ONCT-534 with AR phenotype

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Group I: Dose Level 6: 1200 mg QDExperimental Treatment1 Intervention
1200mg of single agent ONCT-534 to be administered daily in oral tablets
Group II: Dose Level 5: 600mg QDExperimental Treatment1 Intervention
600mg of single agent ONCT-534 to be administered daily in oral tablets
Group III: Dose Level 4: 300mg QDExperimental Treatment1 Intervention
300mg of single agent ONCT-534 to be administered daily in oral tablets
Group IV: Dose Level 3: 160mg QDExperimental Treatment1 Intervention
160mg of single agent ONCT-534 to be administered daily in oral tablets
Group V: Dose Level 2: 80mg QDExperimental Treatment1 Intervention
80mg of single agent ONCT-534 to be administered daily in oral tablets
Group VI: Dose Level 1: 40mg QDExperimental Treatment1 Intervention
40mg of single agent ONCT-534 to be administered daily in oral tablets
Group VII: BID Dose Level 2: 300 mg BIDExperimental Treatment1 Intervention
300mg of single agent ONCT-534 to be administered twice daily in oral tablets
Group VIII: BID Dose Level 1: 160 mg BIDExperimental Treatment1 Intervention
600mg of single agent ONCT-534 to be administered daily in oral tablets

Find a Location

Who is running the clinical trial?

Oncternal Therapeutics, IncLead Sponsor
6 Previous Clinical Trials
223 Total Patients Enrolled
Salim Yazji, MDStudy DirectorOncternal Therapeutics
~10 spots leftby Nov 2025
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