AMT-116 in Patients With Advanced Solid Tumor

• Drug: AMT-116

Key Inclusion Criteria:

• Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
• Age ≥18 years (at the time consent is obtained).
• Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectalrelating to the colon or rectum in the large bowel/intestine, cervical, breast, bladdera hollow, muscular sac in the pelvis that stores urine, gastric, biliary tract, skin squamous cell, liver, and basal cell cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs.
• Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
• Patients must have at least one measurable lesion as per RECIST version 1.1.
• Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status of 0-1.
• Both male and female patients must agree to use effective contraceptive methods.
• Patients must have adequate organ function.
• Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
• Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.
• Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.
• Availability of tumoura tissue mass that forms from groups of unhealthy cells tissuea group of cells that work together to perform a function sample (either an archival specimena sample for investigating (e.g. blood, stools, urine, sputum etc.) or a fresh biopsyremoval of a section of tissue to analyse for cancer cells material) at screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening.