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NCT05047536 (KZR-261 in Advanced Solid Malignancies): BVCT ex-ante prediction vs. reported outcome

On 10 Aug 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 13 Aug 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
NCT05047536
Drug Name
KZR-261
Drug MoA
small molecule SEC61 inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Solid Malignancies
Human Patients
61
Sponsor
Kezar Life Sciences
Phase
Phase 1

Prediction of , index 1743

Prospective Prediction
Prediction Index
1743
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit in OS)
Technical Prediction
FAILURE (statistically insignificant clinical benefit in ORR/PFS)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
3 days in advance
Readout Data Interpretation
0% ORR and trial terminated
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 1 Study of KZR-261, a Small Molecule Sec61 Inhibitor, in Subjects With Advanced Solid Malignancies
Phase
Phase 1
Status
Terminated
Enrollment
61
Lead sponsor
Kezar Life Sciences, Inc.
Conditions
Advanced/Metastatic Solid Tumor
Interventions
DRUG: KZR-261
Design
Single group · None
Primary purpose
Treatment
Start
2021-09-30
Primary completion
2025-01-17
Completion
2025-01-17
Results first posted
2025-12-19
Primary outcomes
  • Number and Percentage of Participants Experiencing Adverse Events as Assessed by CTCAE v5.0 (Part 1 & 2) (20 months)
  • Number and Percentage of Participants Experiencing Dose-limiting Toxicities (28 days)
  • Maximum Plasma Concentration of KZR-261 (Part 1) (Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15)
  • The Plasma Concentration Time Curve of KZR-261 (Part 1) (Cycle 1: Day 1, Cycle 1: Day 15, Cycle 2: Day 1, and Cycle 2: Day 15)

NCT05047536 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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