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NCT05304377 (ELVN-001 in Chronic Myeloid Leukemia): BVCT ex-ante prediction vs. reported outcome

On 18 Mar 2024, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 11 Apr 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05304377
Acronym
CML
Drug Name
ELVN-001
Drug MoA
BCR-ABL1 and T315I selective tyrosine kinase inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Chronic Myeloid Leukemia
Human Patients
180
Sponsor
Enliven Therapeutics
Phase
Phase 1 a/1b

Prediction of , index 1508

Prospective Prediction
Prediction Index
1508
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
24 days in advance
Readout Data Interpretation
44% cumulative MRR even for previously treated with asciminib.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia
Phase
Phase 1
Status
Recruiting
Enrollment
250
Lead sponsor
Enliven Therapeutics
Conditions
Chronic Myeloid Leukemia; Chronic Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive; Cml
Interventions
DRUG: ELVN-001
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2022-05-22
Primary completion
2027-12
Completion
2027-12
Primary outcomes
  • Phase 1a: Incidence of dose limiting toxicities (28 days)
  • Phase 1a: Incidence of adverse events (AEs) (up to 28 days)
  • Phase 1a: Incidence of clinically significant laboratory abnormalities (up to 28 days)
  • Phase 1a: Incidence of clinically significant ECG abnormalities (up to 28 days)
  • Phase 1b: Incidence of adverse events (up to 3 years)

NCT05304377 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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