BioinvestGPT

BioinvestGPT ApS · Research use only

NCT05039177 (ERAS-007 Encorafenib Cetuximab Palbociclib in Advanced Gastrointestinal Malignancies): BVCT ex-ante prediction vs. reported outcome

On 1 Dec 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 17 May 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially insufficient.

Clinical Trial

NCTID
NCT05039177
Acronym
HERKULES-3
Drug Name
ERAS-007 Encorafenib Cetuximab Palbociclib
Drug MoA
ERK1/2 inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
Advanced Gastrointestinal Malignancies
Human Patients
102
Sponsor
Erasca
Phase
Phase 1 Phase 2

Prediction of , index 666

Prospective Prediction
Prediction Index
666
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
168 days in advance
Readout Data Interpretation
40% ORR for treatment-naive cohort which is inferior to the 47.7% cORR achieved by EC+binimetinib (DOI- 10.1200/JCO.22.01693); terminated due to low efficacy.
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant 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 1b/2 Study of Agents Targeting the Mitogen-Activated Protein Kinase Pathway in Patients With Advanced Gastrointestinal Malignancies (HERKULES-3)
Phase
Phase 1, Phase 2
Status
Completed
Enrollment
101
Lead sponsor
Erasca, Inc.
Conditions
Metastatic Colorectal Cancer; Metastatic Pancreatic Ductal Adenocarcinoma
Interventions
DRUG: ERAS-007; DRUG: Encorafenib; DRUG: Cetuximab; DRUG: Palbociclib
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2021-09-20
Primary completion
2025-08-15
Completion
2026-01-26
Primary outcomes
  • Dose Limiting Toxicities (DLT) (Study Day 1 up to Day 29)
  • Maximum Tolerated Dose (MTD) (Study Day 1 up to Day 29)
  • Recommended Dose (RD) (Study Day 1 up to Day 29)
  • Adverse Events (Assessed up to 24 months from time of first dose)

NCT05039177 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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