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NCT06040541 (RMC-9805 in KRAS G12D-Mutant Solid Tumors): BVCT ex-ante prediction vs. reported outcome

On 27 Aug 2024, BioinvestGPT's BVCT predicted technical success and commercial failure for this trial. The 25 Oct 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant (superior in ORR) and commercially TBD (OS data not mature).

Clinical Trial

NCTID
NCT06040541
Drug Name
RMC-9805
Drug MoA
KRAS-G12D-ON inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Neoplasms
Indication
KRAS G12D-Mutant Solid Tumors
Human Patients
444
Sponsor
Revolution Medicines Inc.
Phase
Phase 1 Phase 2

Prediction of , index 1765

Prospective Prediction
Prediction Index
1765
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient (additive) clinical benefit in OS non-superior to tumor-specific SoC)
Technical Prediction
SUCCESS (statistically significant (additive) clinical benefit in ORR/PFS superior to tumor-specific SoC)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
59 days in advance
Readout Data Interpretation
RMC9805 achieved 30% ORR; where is superior to the SoC chemotherapy's 9%-16% ORR (see add'l link below)
Press Release
Additional Readout Data
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant (superior in ORR) and commercially TBD (OS data not mature)
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
Phase 1/1b, Multicenter, Open-Label, Study of RMC 9805 in Participants With Advanced KRASG 12D-Mutant Solid Tumors
Phase
Phase 1
Status
Recruiting
Enrollment
604
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-9805; DRUG: RMC-6236
Design
Non randomized · Parallel · None
Primary purpose
Treatment
Start
2023-09-07
Primary completion
2026-12-31
Completion
2027-04-30
Primary outcomes
  • Adverse events (Up to 3 years)
  • Dose Limiting Toxicities (21 days)

NCT06040541 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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