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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05413421




Registration number
NCT05413421
Ethics application status
Date submitted
7/06/2022
Date registered
10/06/2022
Date last updated
8/11/2024

Titles & IDs
Public title
Study of ORIC-944 in Patients with Metastatic Prostate Cancer
Scientific title
An Open-Label, Phase 1/1b Study of ORIC-944 As a Single Agent or in Combination with an Androgen Receptor Pathway Inhibitor in Patients with Metastatic Prostate Cancer
Secondary ID [1] 0 0
ORIC-944-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ORIC-944
Treatment: Drugs - Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets
Treatment: Drugs - Apalutamide (Erleada™) 60 mg or 240 mg tablets
Treatment: Drugs - Darolutamide (Nubeqa®) 300 mg tablets
Treatment: Drugs - Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets

Experimental: Single Agent Dose Escalation - ORIC-944 dosed orally on a continuous daily dosing regimen in 28-day cycles

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

Experimental: Combination Dose Optimization - 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


Treatment: Drugs: ORIC-944
Oral, once daily, continuous

Treatment: Drugs: Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets
Oral, 1000 mg once daily, continuous

Treatment: Drugs: Apalutamide (Erleada™) 60 mg or 240 mg tablets
Oral, 240 mg once daily, continuous

Treatment: Drugs: Darolutamide (Nubeqa®) 300 mg tablets
Oral, 600 mg twice daily, continuous

Treatment: Drugs: Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Oral, 160 mg once daily, continuous
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Maximum plasma concentration (Cmax)
Timepoint [2] 0 0
28 Days
Primary outcome [3] 0 0
Time to maximum observed concentration (Tmax)
Timepoint [3] 0 0
28 Days
Primary outcome [4] 0 0
Area under the curve (AUC)
Timepoint [4] 0 0
28 Days
Primary outcome [5] 0 0
Apparent plasma terminal elimination half-life (t1/2)
Timepoint [5] 0 0
28 Days
Secondary outcome [1] 0 0
Clinical benefit rate (CBR)
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Objective response rate (ORR)
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Duration of response (DOR)
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Progression-free survival (PFS)
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
On-treatment PSA levels and change from baseline
Timepoint [5] 0 0
36 months

Eligibility
Key inclusion criteria
* 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
* Prior therapies:

Part I (single agent ORIC-944 dose escalation): Any number of prior therapies are allowed, but must have progressed after at least one line of next generation ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) and must not have received more than 2 chemotherapy regimens in the mCRPC setting

Part II (ARPI combination dose escalation): Must have received only 1 prior line of ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in any setting; may have also received up to 1 prior line of chemotherapy in the mCSPC setting

Part III (ARPI combination dose optimization): In addition to up to 1 prior line of chemotherapy in the mCSPC setting:

* Cohorts A and B: received only one 1 prior line of abiraterone in any setting
* Cohorts C and D: received only one 1 prior line of apalutamide, darolutamide, or enzalutamide in any 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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Sydney Adventist Health - Wahroonga
Recruitment hospital [2] 0 0
Bendigo Health - Bendigo
Recruitment postcode(s) [1] 0 0
- Wahroonga
Recruitment postcode(s) [2] 0 0
- Bendigo
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Spain
State/province [11] 0 0
Barcelona
Country [12] 0 0
Spain
State/province [12] 0 0
Madrid
Country [13] 0 0
United Kingdom
State/province [13] 0 0
Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ORIC Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pratik S. Multani, MD
Address 0 0
ORIC Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ORIC Clinical
Address 0 0
Country 0 0
Phone 0 0
650-388-5600
Fax 0 0
Email 0 0
clinical@oricpharma.com
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05413421