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NCT05413421 (ORIC-944 in Metastatic Prostate Cancer): BVCT ex-ante prediction vs. reported outcome

On 11 Oct 2023, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 8 Jan 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: commercially insufficient.

Clinical Trial

NCTID
NCT05413421
Drug Name
ORIC-944
Drug MoA
PRC2 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic Prostate Cancer
Human Patients
42
Sponsor
ORIC Pharmaceuticals
Phase
Phase 1

Prediction of , index 1279

Prospective Prediction
Prediction Index
1279
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
89 days in advance
Readout Data Interpretation
no efficacy data on key secondary endpoints ORR/PFS yet advancing combination therapy forward only (widely accepted strong sign of weak efficacy).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official 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
Phase
Phase 1
Status
Recruiting
Enrollment
275
Lead sponsor
ORIC Pharmaceuticals
Conditions
Metastatic Prostate Cancer
Interventions
DRUG: ORIC-944; DRUG: Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets; DRUG: Apalutamide (Erleada™) 60 mg or 240 mg tablets; DRUG: Darolutamide (Nubeqa®) 300 mg tablets; DRUG: Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-06-01
Primary completion
2027-06
Completion
2028-04
Primary outcomes
  • Recommended Phase 2 Dose (RP2D) (12 months)
  • Maximum plasma concentration (Cmax) (28 Days)
  • Time to maximum observed concentration (Tmax) (28 Days)
  • Area under the curve (AUC) (28 Days)
  • Apparent plasma terminal elimination half-life (t1/2) (28 Days)

NCT05413421 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials