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NCT05198804 (ZN-c3 in 2L advanced ovarian cancer): BVCT ex-ante prediction vs. reported outcome

On 25 Jun 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 29 Jan 2025 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically partially significant (monotherapy for CCNE1+ patients only) yet weak additive efficacy and commercially probably insufficient (combotherapy discontinued).

Clinical Trial

NCTID
NCT05198804
Drug Name
ZN-c3 (azenosertib)
Drug MoA
Wee1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
2L advanced ovarian cancer
Human Patients
117
Sponsor
Zentalis Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 1076

Prospective Prediction
Prediction Index
1076
Prediction Date
Commercial Prediction
overall 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
218 days in advance
Readout Data Interpretation
azenosertib monotherapy 400mg QD5/2 achieved a 31.3% confirmed ORR (5/16) in CCNE1+ patients; azenosertib + niraparib hasn't met the efficacy threshold and further development discontinued
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically partially significant (monotherapy for CCNE1+ patients only) yet weak additive efficacy and commercially probably insufficient (combotherapy discontinued)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1/2 Dose-Escalation and Dose-Expansion Study of ZN-c3 in Combination With Niraparib and ZN-c3 Monotherapy in Subjects With Platinum-Resistant Ovarian Cancer
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
117
Lead sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Conditions
Ovarian Cancer; Platinum-resistant Ovarian Cancer; Primary Peritoneal Carcinoma; Fallopian Tube Cancer
Interventions
DRUG: Azenosertib; DRUG: Niraparib
Design
Non randomized · Single group · None
Primary purpose
Treatment
Start
2022-01-27
Primary completion
2025-10-15
Completion
2026-01-19
Primary outcomes
  • To investigate the safety and tolerability of ZN-c3 in combination with niraparib, including identification of the MTD and RP2D (6 months)
  • To determine the safety and tolerability of ZN-c3 monotherapy (12 months)
  • To investigate the antitumor activity of ZN-c3 monotherapy (12 months)

NCT05198804 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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