A Dose Escalation/Expansion Study of ERAS-601 in Patients With Advanced or Metastatic Solid Tumors

Prior treatment

• Previous treatment with a SHP2 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-601
• Received prior palliative radiation within 7 days of Cycle 1, Day 1
• 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
• History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to the first dose of study treatment

Other illness

• Have primary central nervous system (CNS) disease or known active CNS metastases and/or carcinomatous meningitis
• Active, clinically significant interstitial lung disease or pneumonitis
• 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

Other

• Documented PTPN11 mutations
• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO
• Are pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial

• Age ≥ 18 years
• Willing and able to give written informed consent
• Have histologically or cytologically confirmed advanced or metastatic solid tumor
• 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
• 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