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ORIC-944 for Metastatic Prostate Cancer

Phase 1

Recruiting

Research Sponsored by ORIC Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with metastatic prostate cancer, including those with neuroendocrine prostate cancer (NEPC) and/or small cell features

ECOG performance status of 0 or 1

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to treat prostate cancer that has spread. They are testing to see what dose is safe and effective.

Who is the study for?

This trial is for men with metastatic prostate cancer who've had a bilateral orchiectomy or are on GnRH analogues. They must have progressed after treatment with certain androgen receptor antagonists and can't have had more than two chemo treatments in the mCRPC setting. Participants need to show disease progression, be able to undergo biopsies, have an ECOG status of 0 or 1, and adequate organ function.

What is being tested?

The study aims to determine the optimal dose of ORIC-944 that patients can tolerate and its preliminary effectiveness against metastatic prostate cancer. It includes those with neuroendocrine features who've progressed despite previous therapies.

What are the potential side effects?

While specific side effects of ORIC-944 aren't listed here, common ones for similar drugs include fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, hormonal imbalances, liver issues, and potential heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have prostate cancer that has spread, including types like NEPC.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have had surgery to remove both testicles or am willing to continue treatment to keep my testosterone low.

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My cancer is getting worse, shown by higher PSA levels or new bone/soft tissue issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had severe heart issues or a heart attack in the last 6 months.

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I have symptoms of HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Area under the curve (AUC)

Maximum plasma concentration (Cmax)

+2 more

Secondary study objectives

Clinical benefit rate (CBR)

Duration of response (DOR)

Objective response rate (ORR)

+2 more

Side effects data

From 2021 Phase 3 trial • 32 Patients • NCT01517802

10%

Pulmonary Embolism

Diarrhoea

Fall

Skin Laceration

Cardiac Failure Congestive

Myocardial Infarction

Urinary Retention

Oesophagitis

Musculoskeletal Pain

Acute Kidney Injury

Nausea

Vomiting

Aortic Thrombosis

Hypertension

Dyspnoea

Fatigue

Weight Decreased

Lower Respiratory Tract Infection

Urinary Tract Infection

Dehydration

Cerebrovascular Accident

Encephalopathy

Spinal Cord Compression

Syncope

Cardiac Failure

Upper Limb Fracture

Aortic Valve Replacement

100%

80%

60%

40%

20%

Study treatment Arm

Abiraterone Acetate + Prednisone/Prednisolone

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Single Agent Dose EscalationExperimental Treatment1 Intervention

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

Group II: Combination Dose OptimizationExperimental Treatment3 Interventions

Cohort A and C: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with apalutamide Cohort B and D: ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combination with darolutamide Combinations with abiraterone or enzalutamide may be conducted in the future

Group III: Combination Dose EscalationExperimental Treatment5 Interventions

ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles in combinations with abiraterone, apalutamide, darolutamide, or enzalutamide

0 / 6Eligibility criteria met