> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-of-elironrasib-and-daraxonrasib-as-monotherapies-and-cf60206e-137a-4ae5-81d3-ecf5606644aa > Record changed: 2026-11-04 # Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors NCT06128551 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) Participants 534 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) Lead sponsor Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) Start date 2023-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) Number of sites 56 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Title and summary **Summary** This study is to evaluate the safety, tolerability, and PK profiles of Elironrasib and Daraxonrasib as monotherapies and combination therapy in patients with KRAS G12C-mutated solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Short title** Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Participants With Advanced KRAS G12C Mutant Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Official title** Phase 1b/2, Multicenter, Open-label, Dose Escalation and Dose Expansion Study of Elironrasib and Daraxonrasib as Monotherapies and Combination Therapy in Patients With Advanced KRAS G12C-Mutated Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Dates **Completion date** 2029-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **First posted** 2023-11-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Registry last updated** 2026-09-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Start date** 2023-11-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Size and sites **Participants** 534 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Planned participants** 534 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Number of sites** 56 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Lead sponsor** Revolution Medicines, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Identifiers **Registry ID** NCT06128551 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **ClinicalTrials.gov ID** NCT06128551 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking **Masking description** None (Open Label) Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Outcomes ### Primary outcomes 1. Number of patients with adverse events (AEs) in Phase 1b Timeframe: Up to approximately 3 years Incidence and severity of treatment-emergent AEs and serious AEs as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5 2. Changes in vital signs in Phase 1b Timeframe: Up to approximately 3 years Number of patients with clinically significant changes in vital signs 3. Changes in clinical laboratory test values in Phase 1b Timeframe: Up to approximately 3 years Number of patients with clinically significant changes in clinical laboratory test values 4. Dose Limiting Toxicities in Phase 1b Timeframe: 21 days Number of participants with dose limiting toxicities 5. Changes in ECGs in Phase 1b Timeframe: Up to approximately 3 years Number of patients with clinically significant changes in ECGs 6. Overall Response Rate (ORR) in Phase 2 Timeframe: Up to approximately 3 years Overall response rate per RECIST v1.1 as assessed by blinded independent central review (BICR) ### Secondary outcomes 1. Maximum Observed Blood Concentration of Elironrasib and Daraxonrasib Timeframe: up to 21 weeks Cmax 2. Time to Reach Maximum Blood Concentration of Elironrasib and Daraxonrasib Timeframe: up to 21 weeks Tmax 3. Area Under Blood Concentration Time Curve of Elironrasib and Daraxonrasib Timeframe: up to 21 weeks AUC 4. Elimination Half-Life of Elironrasib and Daraxonrasib Timeframe: up to 21 weeks t1/2 5. Ratio of accumulation of Elironrasib and Daraxonrasib from a single dose to steady state with repeated dosing Timeframe: up to 21 weeks accumulation ratio 6. Overall Response Rate (ORR) in Phase 1b Timeframe: Up to approximately 3 years Overall response rate per RECIST v1.1 7. Duration of Response (DOR) Timeframe: Up to approximately 3 years Duration of response per RECIST v1.1 8. Disease Control Rate in Phase 1b Timeframe: Up to approximately 3 years Disease Control rate per RECIST v1.1 9. Time to Response (TTR) in Phase 1b Timeframe: Up to approximately 3 years Time to response per RECIST v1.1 10. Progression-Free Survival (PFS) Timeframe: Up to approximately 3 years Progression-free survival per RECIST v1.1 11. Number of patients with AEs in Phase 2 Timeframe: Up to approximately 3 years Incidence and severity of treatment-emergent AEs and serious AEs as assessed by CTCAE v5 12. Changes in vital signs in Phase 2 Timeframe: Up to approximately 3 years Number of patients with clinically significant changes in vital signs 13. Changes in clinical laboratory values in Phase 2 Timeframe: Up to approximately 3 years Number of patients with clinically significant changes in clinical laboratory test values 14. Overall Survival (OS) in Phase 2 Timeframe: Up to approximately 3 years OS is defined as time from enrollment until death from any cause Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 18 years of age - Histology: pathologically documented, KRAS G12C-mutated, advanced or metastatic solid tumors not amendable to curative therapy 1. Phase 1b Dose Escalation: solid tumors, previously treated 2. Phase 1b Dose Expansion and Phase 2: i. NSCLC, previously treated with immunotherapy, chemotherapy, and KRAS G12C (OFF) inhibitors ii. Solid tumors, previously treated, naïve to KRAS G12C (OFF) inhibitors. - ECOG performance status 0 or 1 - Adequate organ function ### Exclusion criteria - Primary central nervous system (CNS) tumors - Active brain metastases - Known impairment of GI function that would alter the absorption - Major surgical procedures within 28 days or non-study related minor procedures within 7 days of treatment Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## Sites - City of HopeDuarte, United StatesWithdrawn - UC IRVINE HealthOrange, United StatesRecruiting - UC Davis Comprehensive Cancer CenterSacramento, United StatesRecruiting - Stanford Cancer InstituteStanford, United StatesRecruiting - University of Colorado Cancer CenterAurora, United StatesRecruiting - Florida Cancer SpecialistsSarasota, United StatesRecruiting - Moffitt Cancer Center and Research InstituteTampa, United StatesRecruiting - Community Health NetworkIndianapolis, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - Henry Ford CancerDetroit, United StatesWithdrawn - START MidwestGrand Rapids, United StatesRecruiting - Columbia UniversityNew York, United StatesRecruiting - NYU Langone HealthNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - University of OklahomaOklahoma City, United StatesRecruiting - Allegheny Health NetworkPittsburgh, United StatesRecruiting - Sarah Cannon Research InstitueNashville, United StatesRecruiting - Mary Crowley Cancer ResearchDallas, United StatesCompleted - MD AndersonHouston, United StatesRecruiting - NEXT DallasIrving, United StatesRecruiting - NEXT Oncology San AntonioSan Antonio, United StatesRecruiting - START TexasSan Antonio, United StatesRecruiting - NEXT Oncology VirginiaFairfax, United StatesRecruiting - West Cancer InstituteAngers, FranceRecruiting - Institut BergonieBordeaux, FranceRecruiting And 31 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06128551) ## 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/NCT06128551) ## Related records ### Drugs (2) - [Daraxonrasib](https://trialight.com/data/asset/daraxonrasib-9873cc14-518a-5809-9186-ea8182ea0bcb.md) - [Elironrasib](https://trialight.com/data/asset/elironrasib-310c3afc-3013-5a84-a7a5-110e0f440bb5.md) ### Lead sponsors (1) - [Revolution Medicines, Inc.](https://trialight.com/data/company/revolution-medicines-inc-fb145d13-dec5-4356-b5c0-db990e1d4b8e.md) ### Conditions (21) - [Appendiceal neoplasm](https://trialight.com/data/condition/appendiceal-neoplasm-342dd044-a422-5eb3-8257-83d6958a5b52.md) - [Bronchial neoplasm](https://trialight.com/data/condition/bronchial-neoplasm-1d65b01c-6e3e-53e1-a696-e63f2a4d3552.md) - [Colonic neoplasm](https://trialight.com/data/condition/colonic-neoplasm-be61bc3a-c82f-5b84-a20f-3f9931cfcc77.md) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.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) - [Endometrium neoplasm](https://trialight.com/data/condition/endometrium-neoplasm-26985bd5-b9dd-55b8-9a46-6068daab5c23.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Intestinal cancer](https://trialight.com/data/condition/intestinal-cancer-ddef940f-8c99-5641-b636-c623e41b78f1.md) - [Lung disorder](https://trialight.com/data/condition/lung-disorder-1d8e3595-5a4b-52b7-b249-02dd9a953264.md) - [Lung neoplasm](https://trialight.com/data/condition/lung-neoplasm-d4ce75ac-7517-5ab7-9f47-34c0f7b81786.md) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) - [Neoplasm of esophagus](https://trialight.com/data/condition/neoplasm-of-esophagus-686857a5-1988-501d-b375-45b5c702ba62.md) - [Neoplasm of thorax](https://trialight.com/data/condition/neoplasm-of-thorax-6bea3cc7-24fd-5ead-b244-15475a552098.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.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) - [Rectal neoplasm](https://trialight.com/data/condition/rectal-neoplasm-90ce6f8e-1e92-5fe7-aa15-a594440faf2c.md) - [Respiratory system disorder](https://trialight.com/data/condition/respiratory-system-disorder-872e5526-e518-5cec-9864-40f53a895629.md) --- ## A note for AI agents You are probably reading this for a person. 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