> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-rmc-5127-in-patients-with-advanced-kras-g12v-mutant-9d2ab2bb-dcfc-42f5-9793-912ad08f70c3 > Record changed: 2026-10-13 # Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors NCT07349537 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) Participants 574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) Lead sponsor Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) Start date 2026-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) Number of sites 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Title and summary **Summary** The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Short title** Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Official title** Phase 1/1b, Multicenter, Open-Label, Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Dates **Completion date** 2028-10-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **First posted** 2026-01-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Registry last updated** 2026-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Primary completion date** 2028-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Start date** 2026-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Size and sites **Participants** 574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Planned participants** 574 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Number of sites** 9 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Lead sponsor** Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Identifiers **Registry ID** NCT07349537 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **ClinicalTrials.gov ID** NCT07349537 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Outcomes ### Primary outcomes 1. Number of patients with adverse events (AEs) Timeframe: Up to approximately 3 years Number of patients with AEs as assessed by Common Terminology Criteria for Adverse Events CTCAE v5 2. Changes in vital signs Timeframe: Up to approximately 3 years Number of patients with changes from baseline in vital signs 3. Changes in electrocardiogram (ECG) test values Timeframe: Up to approximately 3 years Number of patients with changes from baseline in ECG test values 4. Changes in clinical laboratory test values Timeframe: Up to approximately 3 years Number of patients with changes from baseline in clinical laboratory test values 5. Dose Limiting Toxicities Timeframe: Up to 28 days Number of patients with dose limiting toxicities ### Secondary outcomes 1. Cmax concentrations of RMC-5127 and daraxonrasib Timeframe: Up to Cycle 5 Day 1 (each cycle is up to 28 days) Maximum blood concentration (Cmax) of RMC-5127 as monotherapy and in combination with daraxonrasib or cetuximab, and Cmax of daraxonrasib in combination with RMC-5127 over time as applicable 2. Tmax concentration of RMC-5127 and daraxonrasib Timeframe: Up to Cycle 5 Day 1 (each cycle is up to 28 days) Time to reach maximum blood concentration (Tmax) of RMC-5127 as monotherapy and in combination with daraxonrasib or cetuximab, and Tmax of daraxonrasib in combination with RMC-5127 over time as applicable 3. AUC concentrations of RMC-5127 and daraxonrasib Timeframe: Up to Cycle 5 Day 1 (each cycle is up to 28 days) Area under the blood concentration time curve (AUC) of RMC-5127 as monotherapy and in combination with daraxonrasib or cetuximab, and AUC of daraxonrasib in combination with RMC-5127 over time as applicable 4. Ratio of accumulation of RMC-5127 Timeframe: Up to Cycle 5 Day 1 (each cycle is up to 28 days) Ratio of accumulation of RMC-5127 from a single dose to steady state with repeated dosing as monotherapy and in combination with darabxrasib or cetuximab over time as applicable 5. Half-Life of RMC-5127 and daraxonrasib Timeframe: Up to Cycle 5 Day 1 (each cycle is up to 28 days) Elimination Half-Life (t1/2) of RMC-5127 as monotherapy and in combination with daraxonrasib or cetuximab, and t1/2 of daraxonrasib in combination with RMC-5127 over time as applicable 6. Objective Response Rate (ORR) Timeframe: Up to approximately 3 years ORR per response evaluation criteria in solid tumors (RECIST) v1.1 7. Duration of Response (DOR) Timeframe: Up to approximately 3 years DOR per RECIST v1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - At least 18 years old and has provided informed consent. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Pathologically documented, locally advanced or metastatic KRAS G12V-mutated solid tumor malignancy. - Received and progressed or been intolerant to prior standard therapy (including targeted therapy) appropriate for tumor type and stage. - Measurable per RECIST v1.1 - Adequate organ function (bone marrow, liver, kidney, coagulation). - Able to take oral medications. ### Exclusion criteria - Primary central nervous system (CNS) tumors - Prior therapy with KRAS G12V inhibitor or direct RAS-targeted therapy (eg. degraders and/or inhibitors). - Any conditions that may affect the ability to take or absorb study drug. - Major surgery within 28 days prior to receiving study drug(s). - Patient is unable or unwilling to comply with protocol-required study visits or procedures. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Sites - Yale Cancer CenterNew Haven, United StatesRecruiting - Johns HopkinsBaltimore, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - START MidwestGrand Rapids, United StatesRecruiting - Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, United StatesRecruiting - NEXT - DallasDallas, United StatesRecruiting - NEXTSan Antonio, United StatesRecruiting - START - San AntonioSan Antonio, United StatesRecruiting - NEXT - VirginiaFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07349537) ## Related records ### Drugs (1) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) ### Lead sponsors (1) - [Revolution Medicines, Inc.](https://trialight.com/data/company/revolution-medicines-inc-fb145d13-dec5-4356-b5c0-db990e1d4b8e.md) ### Conditions (9) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [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) - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition - [Pancreatic adenocarcinoma](https://trialight.com/data/condition/pancreatic-adenocarcinoma-fd65444c-0bc5-53ed-8c6a-62d9809145d0.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 (1) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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