Health TrialsbyHealthPanel

Study of ORIC-944 in Patients With Metastatic Prostate Cancer

ConditionMetastatic Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorORIC Pharmaceuticals

About this trial

The purpose of this study is to establish the safety and preliminary antitumor activity of ORIC-944 as a single agent and in combinations with ARPIs in patients with metastatic prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with metastatic prostate cancer

Must have undergone bilateral orchiectomy or be willing to continue GnRH analogue or antagonist to maintain castrate levels of testosterone

Cohorts A and B: received only one 1 prior line of abiraterone in any setting

Evidence of progressive disease by PCWG3 criteria for study entry

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • ORIC-944

    Drug

    Oral, once daily, continuous

  • Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets

    Drug

    Oral, 1000 mg once daily, continuous

  • Apalutamide (Erleada™) 60 mg or 240 mg tablets

    Drug

    Oral, 240 mg once daily, continuous

  • Darolutamide (Nubeqa®) 300 mg tablets

    Drug

    Oral, 600 mg twice daily, continuous

  • Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets

    Drug

    Oral, 160 mg once daily, continuous

Treatment groups

275 Participants
are divided into 3 treatment groups
Group A: Single Agent Dose EscalationExperimental treatment 1 intervention
Group B: Combination Dose EscalationExperimental treatment 5 interventions
Group C: Combination Dose OptimizationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Recommended Phase 2 Dose (RP2D)

RP2D as determined by interval 3+3 dose escalation design

Time frame
12 months
2

Maximum plasma concentration (Cmax)

PK of ORIC-944 single agent and in combination with an ARPI

Time frame
28 Days
3

Time to maximum observed concentration (Tmax)

PK of ORIC-944 single agent and in combination with an ARPI

Time frame
28 Days
4

Area under the curve (AUC)

PK of ORIC-944 single agent and in combination with an ARPI

Time frame
28 Days

Secondary outcomes

1

Clinical benefit rate (CBR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
36 months
2

Objective response rate (ORR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
36 months
3

Duration of response (DOR)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
36 months
4

Progression-free survival (PFS)

Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ORIC Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
Apply now