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New drug ORIC-944 targets Hard-to-Treat prostate cancer

NCT ID NCT05413421

Disease control Sponsor: ORIC Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This trial investigates a new oral drug called ORIC-944, given alone or combined with standard hormone therapies, for men with metastatic prostate cancer that has spread beyond the prostate. The study aims to find the safest dose and check for early signs that the drug can control the cancer. Participants must have already tried at least one hormone therapy and may have had chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ORIC-944
What this could lead to
If successful, ORIC-944 could offer a new treatment option for men with metastatic prostate cancer that has stopped responding to current hormone therapies.
What could go wrong
This is an early-phase trial focused on safety and dosing, so it is not yet known if ORIC-944 will effectively shrink tumors or improve survival. Side effects are still being identified.
Why investors are watching

ORIC Pharmaceuticals is testing ORIC-944, an experimental drug, in patients with metastatic prostate cancer. The trial checks the drug's safety and whether it shrinks or controls tumors, both alone and with standard hormone therapy. For a small company like ORIC, this early-stage readout matters because it is the main evidence that the drug works in humans.

If it works: If the trial shows ORIC-944 is safe and has clear antitumor activity, the company could advance the drug to later-stage studies. That result would validate its research and potentially attract partners or funding.

If it fails: Early-phase trials often fail because the drug proves unsafe or shows little benefit. A negative or unclear result could force ORIC to abandon the drug, which would be a major setback for a company of its size.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 275 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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: Part I (single agent ORIC-944 dose escalation): Any number of prior therapies are allowed, but must have progressed after at least one line of next generation ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) and must not have received more than 2 chemotherapy regimens in the mCRPC setting Part II (ARPI combination dose escalation): Must have received only 1 prior line of ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in any setting; may have also received up to 1 prior line of chemotherapy in the mCSPC setting Part III (ARPI combination dose optimization): In addition to up to 1 prior line of chemotherapy in the mCSPC setting: * 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 Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    27 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Amarillo Urology Research

    RECRUITING

    Amarillo, Texas, 74035, United States

  • Bendigo Health

    RECRUITING

    Bendigo, Victoria, Australia

  • Comprehensive Urologic Care

    RECRUITING

    Lake Barrington, Illinois, 60010, United States

  • First Urology

    RECRUITING

    Jeffersonville, Indiana, 47130, United States

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Illinois Cancer Specialists

    RECRUITING

    Arlington Heights, Illinois, 60005, United States

  • Karmanos

    RECRUITING

    Detroit, Michigan, 48201, United States

  • Keystone Urology Specialists

    RECRUITING

    Lancaster, Pennsylvania, 17601, United States

  • Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Marlene & Stewart Greenebaum Comprehensive Cancer Center, University of Maryland

    RECRUITING

    Baltimore, Maryland, 21201, United States

  • Maryland Oncology Hematology

    RECRUITING

    Silver Spring, Maryland, 20904, United States

  • Memorial Sloane Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • MidLantic Urology

    NOT_YET_RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Minnesota Oncology Hematology

    RECRUITING

    Minneapolis, Minnesota, 55404, United States

  • NEXT Oncology

    RECRUITING

    Barcelona, Barcelona, Spain

  • NEXT Oncology

    RECRUITING

    Madrid, Spain

  • Peninsula Health

    NOT_YET_RECRUITING

    Frankston, Victoria, Australia

  • Rocky Mountain Cancer Center

    RECRUITING

    Colorado Springs, Colorado, 80907, United States

  • Royal Marsden NHS Foundation Trust

    RECRUITING

    Sutton, Surrey, United Kingdom

  • South Florida Oncology and Hematology

    RECRUITING

    Plantation, Florida, 33322, United States

  • Sydney Adventist Health

    RECRUITING

    Wahroonga, New South Wales, Australia

  • University of Washington, Fred Hutchinson Cancer Center

    RECRUITING

    Seattle, Washington, 98109, United States

  • University of Wisconsin Carbone Cancer Center

    NOT_YET_RECRUITING

    Madison, Wisconsin, 53792, United States

  • Urology Clinics of North Texas

    RECRUITING

    Dallas, Texas, 75231, United States

  • Vall d'Hebron Institute of Oncology

    RECRUITING

    Barcelona, Barcelona, Spain

  • Virginia Cancer Specialists

    NOT_YET_RECRUITING

    Norfolk, Virginia, 23502, United States

  • Virginia Oncology Associates

    RECRUITING

    Fairfax, Virginia, 22031, United States

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