RECRUITING

Study of ORIC-944 in Patients with Metastatic Prostate Cancer

Conditions

Metastatic Prostate Cancer PRC2 dysregulation EED CRPC mCRPC ARPI

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label, Phase 1/1b Study of ORIC-944 As a Single Agent or in Combination with an Androgen Receptor Pathway Inhibitor in Patients with Metastatic Prostate Cancer

Quick Facts

Study Start:2022-06-01

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05413421

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Patients with metastatic prostate cancer * Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone * Prior therapies: * Cohorts A and B: received only one 1 prior line of abiraterone in any setting * Cohorts C and D: received only one 1 prior line of apalutamide, darolutamide, or enzalutamide in any setting: * Evidence of progressive disease by PCWG3 criteria for study entry * rising PSA, defined as a minimum of 2 rising values obtained a minimum of one week apart with the latest result being at least 2.0 ng/mL (or 1.0 ng/mL if PSA rise is the only indication of progression), or * confirmation of 2 new bone lesions on last systemic therapy, or * soft tissue progression per RECIST 1.1 * Measurable and/or evaluable disease by RECIST 1.1 * Agreement and ability to undergo on-study punch skin biopsies and core tumor biopsies * ECOG performance status of 0 or 1 * Adequate organ function	* History or presence of CNS metastases, unless previously treated and stable * History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months * Known, symptomatic human immunodeficiency virus (HIV) infection * Active symptomatic Hepatitis B or C infection; patients with well controlled disease are eligible * Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, short gut syndrome, etc) or other malabsorption syndromes that would reasonably impact drug absorption per investigator judgement * Any other condition or circumstance (eg, clinical, psychological, familial, sociological, inability to swallow oral study drug) that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study

Inclusion Criteria

Exclusion Criteria

* Patients with metastatic prostate cancer
* Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone
* Prior therapies:
* Cohorts A and B: received only one 1 prior line of abiraterone in any setting
* Cohorts C and D: received only one 1 prior line of apalutamide, darolutamide, or enzalutamide in any setting:
* Evidence of progressive disease by PCWG3 criteria for study entry
* rising PSA, defined as a minimum of 2 rising values obtained a minimum of one week apart with the latest result being at least 2.0 ng/mL (or 1.0 ng/mL if PSA rise is the only indication of progression), or
* confirmation of 2 new bone lesions on last systemic therapy, or
* soft tissue progression per RECIST 1.1
* Measurable and/or evaluable disease by RECIST 1.1
* Agreement and ability to undergo on-study punch skin biopsies and core tumor biopsies
* ECOG performance status of 0 or 1
* Adequate organ function

* History or presence of CNS metastases, unless previously treated and stable
* History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months
* Known, symptomatic human immunodeficiency virus (HIV) infection
* Active symptomatic Hepatitis B or C infection; patients with well controlled disease are eligible
* Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, short gut syndrome, etc) or other malabsorption syndromes that would reasonably impact drug absorption per investigator judgement
* Any other condition or circumstance (eg, clinical, psychological, familial, sociological, inability to swallow oral study drug) that, in the opinion of the investigator, may interfere with protocol compliance or contraindicates participation in the study

Contacts and Locations

Study Contact

ORIC Clinical

CONTACT

650-388-5600

clinical@oricpharma.com

Principal Investigator

Pratik S. Multani, MD

STUDY_DIRECTOR

ORIC Pharmaceuticals

Study Locations (Sites)

South Florida Oncology and Hematology

Plantation, Florida, 33322

United States

First Urology

Jeffersonville, Indiana, 47130

United States

Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland

Baltimore, Maryland, 21201

United States

Karmanos

Detroit, Michigan, 48201

United States

Memorial Sloane Kettering Cancer Center

New York, New York, 10065

United States

Levine Cancer Institute

Charlotte, North Carolina, 28204

United States

Keystone Urology Specialists

Lancaster, Pennsylvania, 17601

United States

Urology Clinics of North Texas

Dallas, Texas, 75231

United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, 84112

United States

University of Washington, Fred Hutchinson Cancer Center

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: ORIC Pharmaceuticals

Pratik S. Multani, MD, STUDY_DIRECTOR, ORIC Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-01

Study Completion Date2026-09

Study Record Updates

Study Start Date2022-06-01

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

PRC2 dysregulation
EED
CRPC
mCRPC
ARPI

Additional Relevant MeSH Terms

Metastatic Prostate Cancer