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NCT05067140 (ARV-766 Part A&B ARV-766… in Metastatic Prostate Cancer): BVCT ex-ante prediction vs. reported outcome

On 13 May 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 23 May 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient TBD.

Clinical Trial

NCTID
NCT05067140
Drug Name
ARV-766 Part A&B ARV-766 + Abiraterone Part C&D
Drug MoA
PROTAC-based AR remover
Drug Modality
PROTAC
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Metastatic Prostate Cancer
Human Patients
220
Sponsor
Arvinas
Phase
Phase 1

Prediction of , index 764

Prospective Prediction
Prediction Index
764
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit for the ARV766 + abiraterone combotherapy in OS)
Technical Prediction
SUCCESS (statistically significant clinical benefit in PSA/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
10 days in advance
Readout Data Interpretation
50% PSA50 and 10% TEAE-related discontinuation vs 45% PSA50 for docetaxel doi- 10.1002/pros.22844.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient TBD
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Open-Label, Dose-Escalation and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-766 Monotherapy and in Combination With Abiraterone in Patients With Metastatic Prostate Cancer
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
164
Lead sponsor
Novartis Pharmaceuticals
Conditions
Prostate Cancer Metastatic
Interventions
DRUG: ARV-766; DRUG: Abiraterone; DRUG: Corticosteroid (e.g., prednisone/prednisolone); OTHER: Androgen Deprivation Therapy (ADT)
Design
Randomized · Sequential · None
Primary purpose
Treatment
Start
2021-09-02
Primary completion
2027-05-25
Completion
2027-05-25
Primary outcomes
  • Part A: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment (Up to 28 days)
  • Part C: Incidence and severity of dose limiting toxicities (DLTs) during the first cycle of treatment (Up to 28 Days)
  • Parts A and C: Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) (From first dose through approximately 30 days after last dose)
  • Parts A and C: Incidence of laboratory abnormalities (From first dose through approximately 30 days after last dose)
  • Part B: Prostate-Specific Antigen 30% Response Rate (PSA30) (12 Weeks)

NCT05067140 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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