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

Cancer Categories

Genitourinary (GU)

Karmanos Trial ID

2022-031

NCT ID

NCT05413421

Age Group

Adult

Scope

National

Phase

Phase I

Principal Investigator

Elisabeth
Heath, M.D., FACP
Oncology - Medical View Profile

Objective:

Primary Objectives:

To assess the safety and tolerability of ORIC-944
To assess the pharmacokinetics (PK) of ORIC-944

Secondary Objectives:

To evaluate the preliminary antitumor activity of ORIC-944

Exploratory Objectives:

To evaluate additional indicators of antitumor activity of ORIC-944
To characterize and/or quantify metabolites of ORIC-944 in plasma
To evaluate target engagement and the association of pharmacodynamic (PD) biomarkers with ORIC-944 antitumor activity and/or PK
To evaluate the association between potential predictive biomarkers and antitumor activity of ORIC-944

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Eligibility

Eligibility

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

Locations

Locations

Karmanos Cancer Institute - Detroit Headquarters

4100 John R
Detroit, MI 48201
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Phone: 800-527-6266

Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices