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NCT05128825 (ZN-c3 in High-Grade Serous Ovarian; Fallopian Tube or…): BVCT ex-ante prediction vs. reported outcome

On 25 May 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 18 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05128825
Acronym
DENALI
Drug Name
ZN-c3
Drug MoA
Wee1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
High-Grade Serous Ovarian; Fallopian Tube or Primary Peritoneal Cancer
Human Patients
102
Sponsor
Zentalis Pharmaceuticals
Phase
Phase 2

Prediction of , index 1078

Prospective Prediction
Prediction Index
1078
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit regardless of CCNE1 expression)
Technical Prediction
partial SUCCESS (statistically significant additive clinical benefit in patients with high CCNE1 expression)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
390 days in advance
Readout Data Interpretation
high toxicity resulting in clinical hold.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 2 Open-Label, Multicenter Study To Evaluate Efficacy And Safety Of ZN-c3 In Subjects With High-Grade Serous Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer (DENALI / ZN-c3-005 / GOG-3066)
Phase
Phase 2
Status
Recruiting
Enrollment
310
Lead sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Conditions
High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Interventions
DRUG: azenosertib
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2022-02-17
Primary completion
2026-12-01
Completion
2027-06-30
Primary outcomes
  • Objective Response Rate (ORR) defined by RECIST v1.1 [Part 2] (Up to approximately 12 months from the enrollment of the last subject)

NCT05128825 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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