A Study to Investigate LYL845 in Adults With Solid Tumors

Inclusion Criteria

• •Age ≥ 18 years up to ≤ 75 years at the time of informed consent
• •Confirmed diagnosis of melanoma, non-small cell lung cancer (NSCLC), or colorectal cancer (CRC) that is metastatic or locally advanced or unresectable and is relapsed and/or refractory (R/R) after standard therapy for each tumor histology
• •Participants must have received prior systemic treatment for their metastatic disease or locally advanced disease based on tumor type as follows:
• •Melanoma: participants with disease progression following an immune checkpoint inhibitor (CPI)
• •NSCLC: participants with disease progression following at least 1 approved systemic therapy, including an immune CPI-containing regimen for appropriate patients or an approved targeted therapy for known molecular abnormalities if applicable to their disease
• •CRC: participants with disease progression following at least 1 line of therapy, including a fluoropyrimidine with oxaliplatin or irinotecan. Microsatellite instability (MSI) high/mismatch repair deficient (dMMR) CRC participants must have disease progression following systemic therapy with immune CPIs.
• •Measurable disease including at least 1 lesion that is safely resectable AND a target lesion to measure response and an additional lesion for biopsy
• •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• •Adequate organ and marrow function
• •Women of childbearing potential must have a negative pregnancy test at screening
• •All participants must agree to practice highly effective methods of contraception
• •Fully recovered from toxicity from prior systemic anticancer therapy