Study of ORIC-944 in Patients With Metastatic Prostate Cancer

April 28, 2023 updated by: ORIC Pharmaceuticals

An Open-Label, Phase 1/1b, Study of ORIC-944 in Patients With Metastatic Prostate Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Karmanos
        • Principal Investigator:
          • Elisabeth Heath, MD
        • Contact:
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloane Kettering Cancer Center
        • Principal Investigator:
          • Wassim Abida, MD
        • Contact:
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Levine Cancer Institute
        • Contact:
        • Principal Investigator:
          • Earle Frederick Burgess, III, MD
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17601
        • Recruiting
        • Keystone Urology Specialists
        • Principal Investigator:
          • Paul Sieber, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75231
        • Not yet recruiting
        • Urology Clinics of North Texas
        • Principal Investigator:
          • Matthew Wilner, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute, University of Utah
        • Principal Investigator:
          • Umang Swami, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommended Phase 2 Dose (RP2D)
Time Frame: 12 months
RP2D as determined by interval 3+3 dose escalation design
12 months
Maximum plasma concentration (Cmax)
Time Frame: 28 Days
PK of ORIC-944
28 Days
Time to maximum observed concentration (Tmax)
Time Frame: 28 Days
PK of ORIC-944
28 Days
Area under the curve (AUC)
Time Frame: 28 Days
PK of ORIC-944
28 Days
Apparent plasma terminal elimination half-life (t1/2)
Time Frame: 28 Days
PK of ORIC-944
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: 36 months
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
36 months
Duration of response (DOR)
Time Frame: 36 months
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
36 months
Clinical benefit rate (CBR)
Time Frame: 36 months
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
36 months
Progression-free survival (PFS)
Time Frame: 36 months
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ORIC Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 7, 2022

First Posted (Actual)

June 10, 2022

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORIC-944-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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