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NCT05907304 (naporafenib in RAS-mutant advanced solid tumors): BVCT ex-ante prediction vs. reported outcome

On 25 Jun 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 24 Oct 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant (in ORR) and commercially TBD (OS data not mature).

Clinical Trial

NCTID
NCT05907304
Acronym
SEACRAFT-1
Drug Name
naporafenib (ERAS254)
Drug MoA
RAF inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
RAS-mutant advanced solid tumors
Human Patients
115
Sponsor
Erasca
Phase
Phase 1

Prediction of , index 1130

Prospective Prediction
Prediction Index
1130
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit in ORR/PFS against placebo)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
487 days in advance
Readout Data Interpretation
naporafenib + trametinib achieved only 30% ORR; non-superior to trametinib monotherapy that achieved 33% ORR for advanced melanoma (10.1002/onco.13795)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant (in ORR) and commercially TBD (OS data not mature)
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
An Open-label Study to Assess the Safety and Efficacy of Naporafenib (ERAS-254) Administered With Trametinib in Previously Treated Patients With Locally Advanced Unresectable or Metastatic Solid Tumor Malignancies With RAS Q61X Mutations
Phase
Phase 1
Status
Active not recruiting
Enrollment
86
Lead sponsor
Erasca, Inc.
Conditions
Advanced or Metastatic Solid Tumors
Interventions
DRUG: Naporafenib; DRUG: Trametinib
Design
Single group · None
Primary purpose
Treatment
Start
2023-08-17
Primary completion
2025-07-01
Completion
2026-12
Primary outcomes
  • To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors (Assessed up to 24 months from time of first dose)

NCT05907304 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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