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Study of ORIC-944 in Patients With Metastatic Prostate Cancer

Primary Purpose

Metastatic Prostate Cancer, Neuroendocrine Prostate Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ORIC-944

About this trial

This is an interventional treatment trial for Metastatic Prostate Cancer focused on measuring PRC2 dysregulation, EED, CRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

KarmanosRecruiting
Memorial Sloane Kettering Cancer CenterRecruiting
Levine Cancer InstituteRecruiting
Keystone Urology SpecialistsRecruiting
Urology Clinics of North Texas
Huntsman Cancer Institute, University of UtahRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose Escalation

Arm Description

ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles

Outcomes

Primary Outcome Measures

Recommended Phase 2 Dose (RP2D)

RP2D as determined by interval 3+3 dose escalation design

Maximum plasma concentration (Cmax)

PK of ORIC-944

Time to maximum observed concentration (Tmax)

PK of ORIC-944

Area under the curve (AUC)

PK of ORIC-944

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

PK of ORIC-944

Secondary Outcome Measures

Clinical benefit rate (CBR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Objective response rate (ORR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Duration of response (DOR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Progression-free survival (PFS)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Full Information

NCT ID

NCT05413421

First Posted

June 7, 2022

Last Updated

April 28, 2023

Sponsor

ORIC Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT05413421

Brief Title

Study of ORIC-944 in Patients With Metastatic Prostate Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ORIC Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Prostate Cancer, Neuroendocrine Prostate Cancer

Keywords

PRC2 dysregulation, EED, CRPC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Model Description

Interval 3+3 dose escalation design

Masking

None (Open Label)

Allocation

N/A

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dose Escalation

Arm Type

Experimental

Arm Description

ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles

Intervention Type

Drug

Intervention Name(s)

ORIC-944

Intervention Description

ORIC-944 oral once daily for 28 days

Primary Outcome Measure Information:

Title

Recommended Phase 2 Dose (RP2D)

Description

RP2D as determined by interval 3+3 dose escalation design

Time Frame

12 months

Title

Maximum plasma concentration (Cmax)

Description

PK of ORIC-944

Time Frame

28 Days

Title

Time to maximum observed concentration (Tmax)

Description

PK of ORIC-944

Time Frame

28 Days

Title

Area under the curve (AUC)

Description

PK of ORIC-944

Time Frame

28 Days

Title

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

Description

PK of ORIC-944

Time Frame

28 Days

Secondary Outcome Measure Information:

Title

Clinical benefit rate (CBR)

Description

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time Frame

36 months

Title

Objective response rate (ORR)

Description

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time Frame

36 months

Title

Duration of response (DOR)

Description

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time Frame

36 months

Title

Progression-free survival (PFS)

Description

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time Frame

36 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ORIC Clinical

Phone

650-388-5600

clinical@oricpharma.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pratik S. Multani, MD

Organizational Affiliation

ORIC Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Karmanos

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amber Redmond, BS, CCRC

redmonda@karmanos.org

First Name & Middle Initial & Last Name & Degree

Elisabeth Heath, MD

Facility Name

Memorial Sloane Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lance Glickman

glickml@mskcc.org

First Name & Middle Initial & Last Name & Degree

Wassim Abida, MD

Facility Name

Levine Cancer Institute

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28204

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carrie Chiluck, BSN, RN, OCN, CCRP

carrie.chiluck@atriumhealth.org

First Name & Middle Initial & Last Name & Degree

Earle Frederick Burgess, III, MD

Facility Name

Keystone Urology Specialists

City

Lancaster

State/Province

Pennsylvania

ZIP/Postal Code

17601

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erica Collins, BSN, RN

ericac@keystoneurology.com

First Name & Middle Initial & Last Name & Degree

Paul Sieber, MD

Facility Name

Urology Clinics of North Texas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Matthew Wilner, MD

Facility Name

Huntsman Cancer Institute, University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Caitlin Faust

caitlin.faust@hci.utah.edu

First Name & Middle Initial & Last Name & Degree

Umang Swami, MD

12. IPD Sharing Statement

Learn more about this trial

Study of ORIC-944 in Patients With Metastatic Prostate Cancer

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