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NCT05379985 (RMC-6236 in RAS Mutant Advanced Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 16 Jul 2023, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. 2 readouts followed: 15 Jul 2024, True Negative (TN); 2 Dec 2024, True Negative (TN).

Clinical Trial

NCTID
NCT05379985
Drug Name
RMC-6236
Drug MoA
tri-complex RAS(ON) multi-selective inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
RAS Mutant Advanced Solid Tumors
Human Patients
614
Sponsor
Revolution Medicines
Phase
Phase 1

Prediction of , index 1175

Prospective Prediction
Prediction Index
1175
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit non-superior to RAS(OFF) inhibitors)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
365 days in advance
Readout Data Interpretation
20-21% ORR at week 14 vs 16% ORR achieved by Nal-IRI + 5-FU/LV for any PDAC (see add link for Nal-IRI data in Lancet) or 21% ORR achieved by Sotorasib in CodeBreaK 100 trial NEJM.
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially probably insufficient (weak ORR improvement)
Prediction Classification
True Negative (TN)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
505 days in advance
Readout Data Interpretation
RMC6236 achieved 9% ORR (9% ORR is low and probably non-superior to KRAS(OFF) G12C inhibitors)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically maybe significant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

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

Official title
A Multicenter Open-Label Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
Phase
Phase 1, Phase 2
Status
Recruiting
Enrollment
754
Lead sponsor
Revolution Medicines, Inc.
Conditions
Non-small Cell Lung Cancer (NSCLC); Colorectal Cancer (CRC); Pancreatic Ductal Adenocarcinoma (PDAC); Advanced Solid Tumors
Interventions
DRUG: RMC-6236
Design
Single group · None
Primary purpose
Treatment
Start
2022-05-31
Primary completion
2027-05-31
Completion
2027-07-26
Primary outcomes
  • Incidence and severity of treatment-emergent Adverse Events (AEs) and serious AEs, including incidence and severity of findings in laboratory values and vital signs (up to 2.5 years)
  • Number of Participants with Dose-Limiting Toxicity (DLT) (21 days)

NCT05379985 on ClinicalTrials.gov

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