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NCT05669482 (Avutometinib in 1L Pancreatic Ductal Adenocarcinoma): BVCT ex-ante prediction vs. reported outcome

On 26 Oct 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 22 May 2025 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (ORR) and commercially TBD (PFS/OS data pending).

Clinical Trial

NCTID
NCT05669482
Acronym
RAMP205
Drug Name
Avutometinib (VS-6766)
Drug MoA
MEK inhibitor
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Neoplasms
Indication
1L Pancreatic Ductal Adenocarcinoma (PDAC)
Human Patients
40
Sponsor
Verastem
Phase
Phase 1 Phase 2

Prediction of , index 1812

Prospective Prediction
Prediction Index
1812
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit in OS non-superior to SoC chemotherapy alone)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit in ORR/PFS superior to SoC chemotherapy alone)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
208 days in advance
Readout Data Interpretation
avutometinib + defactinib + gemcitabine plus nab-paclitaxel (GnP) achieved 83% ORR (10/12); superior to GnP’s 63% ORR for 1L PDAC (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (ORR) and commercially TBD (PFS/OS data pending)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Phase 1b/2a Study of Gemcitabine and Nab-paclitaxel in Combination With Avutometinib (VS-6766) and Defactinib in Patients With Previously Untreated Metastatic Adenocarcinoma of the Pancreas
Phase
Phase 1, Phase 2
Status
Active not recruiting
Enrollment
40
Lead sponsor
Verastem, Inc.
Conditions
KRAS Activating Mutation; Metastatic Cancer; Pancreas Cancer; Neoplasms Pancreatic; Malignant Neoplasm of Pancreas
Interventions
DRUG: avutometinib (VS-6766) and defactinib in combination with gemcitabine and nab-paclitaxel
Design
Non randomized · Sequential · None
Primary purpose
Treatment
Start
2023-03-22
Primary completion
2026-08-31
Completion
2027-08-31
Primary outcomes
  • Part A: To determine RP2D for avutometinib (VS-6766) and defactinib in combination gemcitabine and nab-paclitaxel (28 days)
  • To determine the efficacy of the RP2D identified in Part A (6 months)

NCT05669482 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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