The trial is taking place at:

Keystone Urology Specialists | Lancaster, PA

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Study of ORIC-944 in Patients With Metastatic Prostate Cancer


Oric Pharmaceuticals

Status and phase

Phase 1


Neuroendocrine Prostate Cancer
Metastatic Prostate Cancer


Drug: ORIC-944

Study type


Funder types




Details and patient eligibility


The purpose of this study is to establish recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) and preliminary antitumor activity of ORIC-944 in patients with metastatic prostate cancer.

Full 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, single arm, multicenter, dose escalation followed by dose expansion study to establish the recommended phase 2 dose (RP2D) and/or maximum tolerated dose (MTD) and preliminary antitumor activity of ORIC-944 in patients with metastatic prostate cancer, including those with neuroendocrine and/or small cell features, who have exhausted available treatment options.

The study will begin with dose finding in patients with metastatic prostate cancer (Dose Escalation); additional dose expansion cohorts (Dose Expansion), with specific histology, treatment history, and/or expression of a specific biomarker, may be initiated via protocol amendment The study will evaluate escalating dose levels of ORIC-944 administered orally, once daily in 28-day cycles following an interval 3+3 design.


42 estimated patients




18+ years old


No Healthy Volunteers

Inclusion criteria

  • Patients with metastatic prostate cancer, including those with neuroendocrine prostate cancer (NEPC) and/or small cell features

  • Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone

  • Any number of prior therapies are allowed, but must have progressed after at least one line of next generation androgen receptor antagonist (abiraterone, enzalutamide, apalutamide, darolutamide) and must not have received more than 2 chemotherapy regimens in the mCRPC 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

Trial design

Primary purpose




Interventional model

Sequential Assignment


None (Open label)

42 participants in 1 patient group

Dose Escalation
Experimental group
ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles
Drug: ORIC-944

Trial contacts and locations



Central trial contact

ORIC Clinical

Data sourced from

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