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NCT05743036 (ZN-c3 in BRAF V600E mutant colorectal 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 probably insignificant (combotherapy for patients not stratified by CCNE1 expression) yet weak additive efficacy and commercially insufficient (combotherapy discontinued).

Clinical Trial

NCTID
NCT05743036
Drug Name
ZN-c3 (azenosertib)
Drug MoA
Wee1 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
BRAF V600E mutant colorectal cancer
Human Patients
44
Sponsor
Zentalis Pharmaceuticals
Phase
Phase 1 Phase 2

Prediction of , index 1081

Prospective Prediction
Prediction Index
1081
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
218 days in advance
Readout Data Interpretation
azenosertib + encorafenib + cetuximab achieved 35-41% confirmed ORR as 1L treatment yet 0% confirmed ORR as 2L treatment. Hence; azenosertib + encorafenib + cetuximab hasn't met the efficacy threshold and further development discontinued
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant (combotherapy for patients not stratified by CCNE1 expression) yet weak additive efficacy and commercially 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, Open-Label, Multi-Center Study of ZN-c3 Administered in Combination With Encorafenib and Cetuximab in Adults With Metastatic Colorectal Cancer
Phase
Phase 1
Status
Terminated
Enrollment
44
Lead sponsor
K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
Conditions
Metastatic Colorectal Cancer
Interventions
DRUG: ZN-c3; DRUG: Encorafenib; DRUG: Cetuximab
Design
Randomized · Sequential · None
Primary purpose
Treatment
Start
2023-02-27
Primary completion
2024-07-16
Completion
2025-07-09
Primary outcomes
  • Dose Escalation Phase - Incidence of Dose Limiting Toxicities (DLTs) (From Lead-in Day -1 to Cycle 1 Day 28)
  • Dose Expansion Phase - Objective response rate (ORR) (From first dose of any study intervention every 8 weeks during treatment, up to 12 months)

NCT05743036 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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