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NCT05131022 (NX-5948 in Relapsed/Refractory B-cell Malignancies): BVCT ex-ante prediction vs. reported outcome

On 20 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 19 Oct 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient (inferior to SoC BTK inhibitors).

Clinical Trial

NCTID
NCT05131022
Drug Name
NX-5948
Drug MoA
BTK degrader
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Relapsed/Refractory B-cell Malignancies
Human Patients
292
Sponsor
Nurix Therapeutics
Phase
Phase 1

Prediction of , index 1329

Prospective Prediction
Prediction Index
1329
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit inferior to SoC BTK inhibitors)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
334 days in advance
Readout Data Interpretation
NX5948 achieved 69.2%; which is inferior to acalabrutinib's 80-85% ORR (see doi.org/10.1182/bloodadvances.2023011307)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially insufficient (inferior to SoC BTK inhibitors)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed/Refractory B-cell Malignancies
Phase
Phase 1
Status
Recruiting
Enrollment
572
Lead sponsor
Nurix Therapeutics, Inc.
Conditions
Chronic Lymphocytic Leukemia (CLL); Small Lymphocytic Lymphoma (SLL); Diffuse Large B Cell Lymphoma (DLBCL); Follicular Lymphoma (FL); Mantle Cell Lymphoma (MCL); Marginal Zone Lymphoma (MZL); Waldenstrom Macroglobulinemia (WM); Primary Central Nervous System Lymphoma (PCNSL); Secondary Central Nervous System Lymphoma (SCNSL)
Interventions
DRUG: NX-5948
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-04-13
Primary completion
2027-01
Completion
2028-01
Primary outcomes
  • Number of participants with protocol specified dose-limiting toxicities (Up to 24 months)
  • To establish the maximum tolerated dose and/or recommended Phase 1b dose(s) (Up to 24 months)
  • To evaluate the anti-tumor activity of NX-5948 in the dose levels selected for Phase 1b safety expansion based on overall response rate (ORR) as assessed by Investigator (Up to 3 years)
  • Number of participants with treatment-emergent adverse events (TEAEs); Grade 3, 4, 5 TEAEs, serious adverse events (SAEs), TEAEs leading to study drug discontinuation, deaths due to TEAEs, and all deaths (Up to 6 years)
  • To further evaluate the anti-tumor activity of NX-5948 in patients with CLL/SLL at the dose identified in Phase 1b Part 1 based on overall response rate (ORR) as assessed by Investigator (Up to 3 years)

NCT05131022 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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