> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-ras-on-inhibitors-in-patients-with-gastrointestinal-a6bfb802-4ce7-4027-9b6c-14758e5e11ee > Record changed: 2026-10-13 # Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors NCT06445062 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) Participants 1,130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) Lead sponsor Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) Start date 2024-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) Number of sites 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Title and summary **Summary** The purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The current subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Short title** Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Official title** A Platform Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Dates **Completion date** 2027-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **First posted** 2024-06-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Registry last updated** 2026-07-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Primary completion date** 2027-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Start date** 2024-05-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Size and sites **Participants** 1,130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Planned participants** 1,130 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Protocol amendments** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Number of sites** 32 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Lead sponsor** Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Identifiers **Registry ID** NCT06445062 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **ClinicalTrials.gov ID** NCT06445062 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Outcomes ### Primary outcomes 1. Adverse events Timeframe: Up to 3 years Evaluate the safety and tolerability in the study population characterized by incidence, abnormal laboratory assessments, severity, and seriousness of adverse events in relation to the study treatment. 2. Dose limiting toxicities Timeframe: 28 days Number of participants with dose limiting toxicities ### Secondary outcomes 1. Pharmacokinetics of RMC-6236 and RMC-9805 Timeframe: 21 weeks Blood concentration of RMC-6236 and RMC-9805 over time 2. ORR Timeframe: Up to 3 years Overall Response Rate per RECIST v1.1 3. DOR Timeframe: Up to 3 years Duration of Response per RECIST v1.1 4. DCR Timeframe: Up to 3 years Incidence of Response per RECIST v1.1 5. TTR Timeframe: Up to 3 years Time to Response per RECIST v1.1 6. PFS Timeframe: Up to 3 years Progression Free Survival per RECIST v1.1 7. OS Timeframe: Up to 3 years Overall Survival Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria All Patients (unless otherwise noted): - ≥ 18 years of age - ECOG PS is 0 to 1 - Adequate organ function as outlined by the study - Pathologically or cytologically documented pancreatic carcinoma or poorly differentiated pancreatic carcinoma with metastatic disease or RAS-mutated, histologically or cytologically confirmed colorectal adenocarcinoma with documented unresectable or metastatic disease (Subprotocol A, B, and C) - Presence of RAS G12D mutation (Subprotocol D, E, F) ### Exclusion criteria All Patients: - Primary central nervous system (CNS) tumors - Impaired gastrointestinal (GI) function that may significantly alter the absorption of RMC drugs - Major surgery within 28 days of first dose Other inclusion/exclusion criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Sites - Ironwood Cancer and Research CentersChandler, United StatesRecruiting - Mayo Clinic HospitalPhoenix, United StatesRecruiting - HonorHealth Research InstituteScottsdale, United StatesRecruiting - UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting - Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos Angeles, United StatesRecruiting - UCLA Hematology/Oncology- Santa MonicaLos Angeles, United StatesRecruiting - University of Colorado Hospital-Anschutz Cancer PavilionAurora, United StatesRecruiting - Yale-New Haven Hospital-Yale Cancer CenterNew Haven, United StatesRecruiting - Mayo Clinic Cancer CenterJacksonville, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - The University of Kansas Clinical Research CenterWestwood, United StatesRecruiting - The Sidney Kimmel Comprehensive Cancer Center at John HopkinsBaltimore, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - Mayo ClinicRochester, United StatesRecruiting - Nebraska Cancer SpecialistsOmaha, United StatesRecruiting - University of Nebraska Medical CenterOmaha, United StatesRecruiting - Atlantic Health SystemMorristown, United StatesRecruiting - Northwell Health / RJ Zuckerberg Cancer CenterLake Success, United StatesRecruiting - Columbia University Medical CenterNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer Center Main CampusNew York, United StatesRecruiting - Duke University Medical CenterDurham, United StatesRecruiting - University of Cincinnati Medical CenterCincinnati, United StatesRecruiting - Stephenson Cancer CenterOklahoma City, United StatesRecruiting - Hospital of the University of PennsylvaniaPhiladelphia, United StatesRecruiting And 7 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## References - PubMed 40056080 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40056080/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06445062) ## Related records ### Drugs (5) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Gemcitabine](https://trialight.com/data/asset/gemcitabine-40c84c8f-1f08-4402-bce9-f31ff283382e.md) - [Paclitaxel](https://trialight.com/data/asset/paclitaxel-889db92c-df97-46a6-bf1c-74974a87fa75.md) ### Lead sponsors (1) - [Revolution Medicines, Inc.](https://trialight.com/data/company/revolution-medicines-inc-fb145d13-dec5-4356-b5c0-db990e1d4b8e.md) ### Conditions (6) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Primary condition - [Colorectal carcinoma](https://trialight.com/data/condition/colorectal-carcinoma-51401c02-7884-5c5c-bb91-90106e7d0d4a.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Digestive system neoplasm](https://trialight.com/data/condition/digestive-system-neoplasm-2ebb9146-1d78-515a-92a3-749515a27d44.md) - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) ### Targets (32) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [POLA1](https://trialight.com/data/target/pola1-6c14f4ad-287d-5db2-9291-d03132327a82.md) - [POLA2](https://trialight.com/data/target/pola2-d3a56190-bd73-5313-bb70-9a3a40afed0e.md) - [POLD1](https://trialight.com/data/target/pold1-03b091bf-5e97-5f8d-9b70-732298285b52.md) - [POLD2](https://trialight.com/data/target/pold2-ef9ce07c-4a48-5e3d-bbde-df8a0c94ea7e.md) - [POLD3](https://trialight.com/data/target/pold3-26e8bdf0-8a6f-54ca-b333-219fdda28006.md) - [POLD4](https://trialight.com/data/target/pold4-64da7b33-a969-536b-8f29-2d4780a3cc1e.md) - [POLE](https://trialight.com/data/target/pole-7c5bd469-ec09-5280-b403-49a06f1d7fb0.md) - [POLE2](https://trialight.com/data/target/pole2-38b134ac-c316-5bbf-85bf-984c1e39a855.md) - [POLE3](https://trialight.com/data/target/pole3-5dc00842-1a0c-5f94-aa3c-dd7ba00cf923.md) - [PRIM1](https://trialight.com/data/target/prim1-c2f41ef1-9a92-5cd5-a6b1-e112bb5c39d3.md) - [PRIM2](https://trialight.com/data/target/prim2-bc77e1b7-71ef-588f-9a25-84ea15688940.md) - [RRM1](https://trialight.com/data/target/rrm1-fb8ba3a4-5a80-5324-8675-2fd574e5088f.md) - [RRM2](https://trialight.com/data/target/rrm2-391b8748-e8c4-59d1-9b4e-006b20426d67.md) - [RRM2B](https://trialight.com/data/target/rrm2b-b1c2454b-b304-5721-ace1-10707ba66f06.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) --- ## A note for AI agents You are probably reading this for a person. 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