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Metastatic Prostate CancerPhase 1NCT05413421

Study of ORIC-944 in Patients With Metastatic Prostate Cancer

A Phase 1 study testing ORIC-944, Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets and Apalutamide (Erleada™) 60 mg or 240 mg tablets in people with Metastatic Prostate Cancer, run by ORIC Pharmaceuticals at 27 sites in 4 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Metastatic Prostate Cancer
What is being tested?
ORIC-944, Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets and Apalutamide (Erleada™) 60 mg or 240 mg tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
275 participants
Where
27 sitesin 4 countries
Study dates
1 Jun 2022to Apr 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 16Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

27 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

ORIC Clinical contact

650-388-5600

clinical@oricpharma.com

27 sites in 4 countries

United States20 sites, 20 recruiting

  • Amarillo Urology Research

    Amarillo, Texas, 74035

    Recruiting

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

    Recruiting

  • MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004

    Not yet recruiting

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

    Baltimore, Maryland, 21201

    Recruiting

  • Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Recruiting

  • Rocky Mountain Cancer Center

    Colorado Springs, Colorado, 80907

    Recruiting

  • Urology Clinics of North Texas

    Dallas, Texas, 75231

    Recruiting

  • Karmanos

    Detroit, Michigan, 48201

    Recruiting

  • Virginia Oncology Associates

    Fairfax, Virginia, 22031

    Recruiting

  • First Urology

    Jeffersonville, Indiana, 47130

    Recruiting

  • Comprehensive Urologic Care

    Lake Barrington, Illinois, 60010

    Recruiting

  • Keystone Urology Specialists

    Lancaster, Pennsylvania, 17601

    Recruiting

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

    Not yet recruiting

  • Minnesota Oncology Hematology

    Minneapolis, Minnesota, 55404

    Recruiting

  • Memorial Sloane Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • Virginia Cancer Specialists

    Norfolk, Virginia, 23502

    Not yet recruiting

  • South Florida Oncology and Hematology

    Plantation, Florida, 33322

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Recruiting

  • University of Washington, Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

    Recruiting

  • Maryland Oncology Hematology

    Silver Spring, Maryland, 20904

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • Bendigo Health

    Bendigo, Victoria

    Recruiting

  • Peninsula Health

    Frankston, Victoria

    Not yet recruiting

  • Sydney Adventist Health

    Wahroonga, New South Wales

    Recruiting

Other trials in Australia

Spain3 sites, 3 recruiting

  • NEXT Oncology

    Barcelona, Barcelona

    Recruiting

  • Vall d'Hebron Institute of Oncology

    Barcelona, Barcelona

    Recruiting

  • NEXT Oncology

    Madrid

    Recruiting

Other trials in Spain

United Kingdom1 site, 1 recruiting

  • Royal Marsden NHS Foundation Trust

    Sutton, Surrey

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

ORIC-944 is a potent, highly selective, allosteric, orally bioavailable, small molecule inhibitor of PRC2 via binding the embryonic ectoderm development (EED) subunit.

This is a first-in-human, open-label, multicenter, dose escalation study of ORIC-944 as a single agent (Part I) or in combination with an Androgen Receptor Pathway Inhibitor (ARPI) (Part II) to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combination with ARPIs in patients with metastatic prostate cancer. Part III of the protocol (dose optimization) will explore two potential dose levels of ORIC-944 selected from Part II in combination with ARPIs to select the final RP2D for each combination across two separate patient populations.

Being tested
ORIC-944, Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets, Apalutamide (Erleada™) 60 mg or 240 mg tablets, Darolutamide (Nubeqa®) 300 mg tablets, Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Keywords
PRC2 dysregulation, EED, CRPC, mCRPC, ARPI
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ORIC-944Drug

    Oral, once daily, continuous

  • Abiraterone acetate (Zytiga®) 250 mg or 500 mg tabletsDrug

    Oral, 1000 mg once daily, continuous

  • Apalutamide (Erleada™) 60 mg or 240 mg tabletsDrug

    Oral, 240 mg once daily, continuous

  • Darolutamide (Nubeqa®) 300 mg tabletsDrug

    Oral, 600 mg twice daily, continuous

  • Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tabletsDrug

    Oral, 160 mg once daily, continuous

Study groups in NCT05413421
Study groupRoleWhat they receive
Single Agent Dose EscalationExperimentalORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles
Receives: Drug: ORIC-944
Combination Dose EscalationExperimentalORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combinations with abiraterone, apalutamide, darolutamide, or enzalutamide
Receives: Drug: ORIC-944; Drug: Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets; Drug: Apalutamide (Erleada™) 60 mg or 240 mg tablets; Drug: Darolutamide (Nubeqa®) 300 mg tablets; Drug: Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Combination Dose OptimizationExperimentalCohort A and C: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with apalutamide Cohort B and D: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with darolutamide Combinations with abiraterone or enzalutamide may be conducted in the future
Receives: Drug: ORIC-944; Drug: Apalutamide (Erleada™) 60 mg or 240 mg tablets; Drug: Darolutamide (Nubeqa®) 300 mg tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended Phase 2 Dose (RP2D)

    RP2D as determined by interval 3+3 dose escalation design

    Measured: 12 months

  2. Maximum plasma concentration (Cmax)

    PK of ORIC-944 single agent and in combination with an ARPI

    Measured: 28 Days

  3. Time to maximum observed concentration (Tmax)

    PK of ORIC-944 single agent and in combination with an ARPI

    Measured: 28 Days

  4. Area under the curve (AUC)

    PK of ORIC-944 single agent and in combination with an ARPI

    Measured: 28 Days

  5. Apparent plasma terminal elimination half-life (t1/2)

    PK of ORIC-944 single agent and in combination with an ARPI

    Measured: 28 Days

Secondary outcomes (5)

  1. Clinical benefit rate (CBR)

    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 36 months

  2. Objective response rate (ORR)

    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 36 months

  3. Duration of response (DOR)

    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 36 months

  4. Progression-free survival (PFS)

    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: 36 months

  5. On-treatment PSA levels and change from baseline

    Prostate cancer working group 3 criteria (PCWG3)

    Measured: 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start1 Jun 2022
  3. Primary completionJun 2027 (estimated)
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Interval 3+3 dose escalation design
Masking
None (open label)
Enrolment
275 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413421
Sponsor's protocol ID
ORIC-944-01
Status last verified
Jul 2026
First submitted
7 Jun 2022
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ORIC-944, Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets and Apalutamide (Erleada™) 60 mg or 240 mg tablets in people with Metastatic Prostate Cancer, run by ORIC Pharmaceuticals at 27 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Australia, Spain, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact ORIC Clinical (650-388-5600, clinical@oricpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase 2 Dose (RP2D) (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05413421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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