Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations

Inclusion criteria

• Aged ≥18 years old at the time of informed consent
• Able to provide informed consent voluntarily before any study-related activities and according to local guidelines
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Have an estimated life expectancy ≥ 12 weeks
• Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.
• Documentation of KRAS/NRAS/HRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory
• Have consented to provide archival tumor tissue collected within 3 years or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
• Have adequate organ functions
• Have discontinued all previous treatments for cancer with resolution of any adverse events (AEs) to ≤ Grade 1

Exclusion criteria

• Are currently enrolled in a clinical study involving an investigational product or any other type of medical research
• Have tumors previously tested positive for Class I BRAF mutations i.e. V600X
• Prior treatment with a pan-RAS(ON) inhibitor
• Gastrointestinal conditions that may interfere with drug absorption
• Have a serious concomitant systemic disorder
• Have a serious pre-existing medical condition(s)
• Prior or second concurrent primary malignancies
• Moderate or severe cardiovascular disease
• Have symptomatic central nervous system (CNS) malignancy or metastasis