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Study of ORIC-944 in Patients With Metastatic Prostate Cancer

NCT05413421 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-08-11

No results posted yet for this study

Summary

The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer.

Conditions

Interventions

DRUG

ORIC-944

Oral, once daily, continuous

DRUG

Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets

Oral, 1000 mg once daily, continuous

DRUG

Apalutamide (Erleada™) 60 mg or 240 mg tablets

Oral, 240 mg once daily, continuous

DRUG

Darolutamide (Nubeqa®) 300 mg tablets

Oral, 600 mg twice daily, continuous

DRUG

Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets

Oral, 160 mg once daily, continuous

Sponsors & Collaborators

  • ORIC Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Pratik S. Multani, MD · ORIC Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-12-31
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Spain
  • 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 NCT05413421 on ClinicalTrials.gov