> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-eras-0015-in-patients-with-advanced-or-metastatic-b3d7bace-2f84-43cf-846b-ff6436a19088 > Record changed: 2026-10-13 # A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors NCT06983743 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) Participants 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) Lead sponsor Erasca, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) Start date 2025-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) Number of sites 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Title and summary **Summary** The main purpose of the study is to assess whether the study drug, ERAS-0015, is safe and tolerable when administered to patients with advanced or metastatic solid tumors with certain RAS mutations. ERAS-0015 will be given alone or in combination with other treatments. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Acronym** AURORAS-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Short title** A Study of ERAS-0015 in Patients With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Official title** A Phase 1 First-in-Human Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of ERAS-0015 Monotherapy and in Combination in Patients Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **First posted** 2025-05-21 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Registry last updated** 2026-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Primary completion date** 2028-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Start date** 2025-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Size and sites **Participants** 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Planned participants** 600 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Number of sites** 8 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Lead sponsor** Erasca, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Identifiers **Registry ID** NCT06983743 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **ClinicalTrials.gov ID** NCT06983743 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Outcomes ### Primary outcomes 1. Dose Limiting Toxicities (DLT) Timeframe: Study Day 1 up to Day 21 Based on toxicities observed 2. Maximum tolerated dose (MTD) Timeframe: Study Day 1 up to Day 21 Based on toxicities observed 3. Recommended dose for expansion (RDE) Timeframe: Study Day 1 up to Day 21 Based on toxicities observed 4. Adverse Events Timeframe: Study Day 1 up to Day 21 Incidence and severity of treatment-emergent AEs and serious AEs 5. Plasma concentration (Cmax) Timeframe: Study Day 1 up to 65 Maximum plasma concentration of ERAS-0015 6. Time to achieve Cmax (Tmax) Timeframe: Study Day 1 up to 65 Time to achieve maximum plasma concentration of ERAS-0015 7. Area under the curve Timeframe: Study Day 1 up to 65 Area under the plasma concentration-time curve of ERAS-0015 8. Half-life Timeframe: Study Day 1 up to 65 Half-life of ERAS-0015 ### Secondary outcomes 1. Objective Response Rate (ORR) Timeframe: Assessed up to 24 months from time of first dose Based on assessment of radiographic imaging per RECIST version 1.1 2. Duration of Response (DOR) Timeframe: Assessed up to 24 months from time of first dose Based on assessment of radiographic imaging per RECIST version 1.1 3. Time to Response (TTR) Timeframe: Assessed up to 24 months from time of first dose Based on assessment of radiographic imaging per RECIST version 1.1 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 99 Years **Healthy volunteers** No ### Inclusion criteria - Age ≥ 18 years - Willing and able to give written informed consent - Pathological documentation of tumor type and mutation prior to the first dose of study drug(s), for applicable cohorts. - There is no available standard systemic therapy available for the patient's tumor histology and/or molecular biomarker profile; or standard therapy is intolerable, not effective, or not accessible; or patient has refused standard therapy. Does not apply to newly diagnosed Pancreatic Ductal Carcinoma (PDAC) cohort. - Able to swallow oral medication - Have Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1 - Adequate cardiovascular, hematological, liver, and renal function - Willing to comply with all protocol-required visits, assessments, and procedures ### Exclusion criteria - Previous treatment with a RAS inhibitor - Is currently receiving another study therapy or has participated in a study of an investigational agent and received study therapy within 4 weeks of the first dose of ERAS-0015 - Received prior palliative radiation within 14 days of Cycle 1, Day 1 - Have primary central nervous system (CNS) tumors - Prior surgery (e.g., gastric bypass surgery, gastrectomy) or gastrointestinal dysfunction (e.g., Crohn's disease, ulcerative colitis, short gut syndrome) that may affect drug absorption - Have any underlying medical condition, psychiatric condition, or social situation that, in the opinion of the Investigator, would compromise study administration as per protocol or compromise the assessment of AEs - Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Sites - Providence Medical GroupSanta Rosa, United StatesRecruiting - Florida Cancer SpecalistsSarasota, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - Massachusetts General Hospital (MG)Boston, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - The University of Texas MD Anderson Cancer CenterHouston, United StatesRecruiting - University of Texas at TylerTyler, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## References ### Other registry identifiers (2) - 2026-525794-39-00 - KEYNOTE-G59 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06983743) ## Related records ### Drugs (1) - [Fluticasone](https://trialight.com/data/asset/fluticasone-07b854dc-6b49-4d3b-8c5a-54e2b7a89943.md) ### Collaborators (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Lead sponsors (1) - [Erasca, Inc.](https://trialight.com/data/company/erasca-inc-b1053fe3-c6e0-47b4-8c8b-1bbf37590c5e.md) ### Conditions (2) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) --- ## A note for AI agents You are probably reading this for a person. 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