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RecruitingPhase 1

Study of ORIC-944 in Patients With Metastatic Prostate Cancer

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ORIC-944 alone and with drugs called ARPIs, which block male hormones or their effects. It is for people with prostate cancer that has spread to other parts of the body. Researchers will check safety and look for early signs that treatment works against the 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have prostate cancer that has spread to other parts of the body.
  • Have had both testicles removed, or be willing to keep taking medicine to keep testosterone very low.
  • Part I: Cancer must have worsened after at least one ARPI treatment: abiraterone, apalutamide, darolutamide, or enzalutamide. No more than 2 chemotherapy treatments are allowed after the cancer stopped responding to treatment that lowers testosterone.
  • Part II: Must have had exactly 1 ARPI treatment. Up to 1 chemotherapy treatment is also allowed while the cancer still responded to treatment that lowers testosterone.
  • Part III: Groups A and B must have had exactly 1 prior abiraterone treatment. Groups C and D must have had exactly 1 prior treatment with apalutamide, darolutamide, or enzalutamide. Up to 1 chemotherapy treatment is also allowed while the cancer still responded to treatment that lowers testosterone.
  • Have cancer that is getting worse based on rising PSA blood test results, new spots in bones, or growth in other tissues. The cancer must be measurable or able to be checked using the study's rules.
  • Be willing and able to have small samples of skin and tumor tissue taken during the study.
  • Be fully active or limited only in hard physical activity, and have organs that work well enough for the study.

Who can't join

  • Cancer that has spread to the brain or spinal cord, unless it was treated and is stable.
  • A history of severe heart failure or severe heart muscle disease not caused by blocked blood flow; or unstable or poorly controlled chest pain, a heart attack, or an abnormal rhythm in the heart's lower chambers within the past 6 months.
  • Known HIV infection that causes symptoms.
  • Active hepatitis B or C, infections that affect the liver, with symptoms. Well-controlled disease is allowed.
  • Active digestive disease, such as Crohn's disease or ulcerative colitis, or another condition that may keep the body from absorbing the study drug.
  • Any other health or life issue that the study doctor thinks could make participation unsafe or make study rules hard to follow, including being unable to swallow the study drug.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (20)

CO

FL

IL

IN

MD

MI

MN

NC

NY

PA

TX

UT

VA

WA

WI