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Study of ORIC-944 in Patients With Metastatic Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05413421
Recruitment Status : Recruiting
First Posted : June 10, 2022
Last Update Posted : May 3, 2023
Sponsor:
Information provided by (Responsible Party):
ORIC Pharmaceuticals

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Prostate Cancer Neuroendocrine Prostate Cancer Drug: ORIC-944 Phase 1

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, 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Intervention Model Description: Interval 3+3 dose escalation design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 1/1b, Study of ORIC-944 in Patients With Metastatic Prostate Cancer
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose Escalation
ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles
 Drug: ORIC-944
ORIC-944 oral once daily for 28 days


Outcome Measures
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Primary Outcome Measures :
  1. Recommended Phase 2 Dose (RP2D) [ Time Frame: 12 months ]
    RP2D as determined by interval 3+3 dose escalation design

  2. Maximum plasma concentration (Cmax) [ Time Frame: 28 Days ]
    PK of ORIC-944

  3. Time to maximum observed concentration (Tmax) [ Time Frame: 28 Days ]
    PK of ORIC-944

  4. Area under the curve (AUC) [ Time Frame: 28 Days ]
    PK of ORIC-944

  5. Apparent plasma terminal elimination half-life (t1/2) [ Time Frame: 28 Days ]
    PK of ORIC-944


Secondary Outcome Measures :
  1. Clinical benefit rate (CBR) [ Time Frame: 36 months ]
    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  2. Objective response rate (ORR) [ Time Frame: 36 months ]
    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  3. Duration of response (DOR) [ Time Frame: 36 months ]
    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  4. Progression-free survival (PFS) [ Time Frame: 36 months ]
    Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05413421


Contacts
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Contact: ORIC Clinical 650-388-5600 clinical@oricpharma.com

Locations
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United States, Michigan
Karmanos Recruiting
Detroit, Michigan, United States, 48201
Contact: Amber Redmond, BS, CCRC       redmonda@karmanos.org   
Principal Investigator: Elisabeth Heath, MD         
United States, New York
Memorial Sloane Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Lance Glickman       glickml@mskcc.org   
Principal Investigator: Wassim Abida, MD         
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Carrie Chiluck, BSN, RN, OCN, CCRP       carrie.chiluck@atriumhealth.org   
Principal Investigator: Earle Frederick Burgess, III, MD         
United States, Pennsylvania
Keystone Urology Specialists Recruiting
Lancaster, Pennsylvania, United States, 17601
Contact: Erica Collins, BSN, RN       ericac@keystoneurology.com   
Principal Investigator: Paul Sieber, MD         
United States, Texas
Urology Clinics of North Texas Not yet recruiting
Dallas, Texas, United States, 75231
Principal Investigator: Matthew Wilner, MD         
United States, Utah
Huntsman Cancer Institute, University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Caitlin Faust       caitlin.faust@hci.utah.edu   
Principal Investigator: Umang Swami, MD         
Sponsors and Collaborators
ORIC Pharmaceuticals
Investigators
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Study Director: Pratik S. Multani, MD ORIC Pharmaceuticals
More Information
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Responsible Party: ORIC Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05413421    
Other Study ID Numbers: ORIC-944-01
First Posted: June 10, 2022    Key Record Dates
Last Update Posted: May 3, 2023
Last Verified: April 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ORIC Pharmaceuticals:
PRC2 dysregulation
EED
CRPC
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases