AMT-253 in Patients With Advanced Solid Tumours

Inclusion Criteria:

• 1. Patients must be willing and able to understand and sign the ICF, and to adhere tothe study visit schedule and other protocol requirements.
• 2. Patients with histologically confirmed melanoma or other advanced solid tumor.
• 3. Patients who have undergone at least one systemic therapy and have radiologicallyor clinically determined progressive disease (PD) during or after most recent line oftherapy, and for whom no further standard therapy is available, or who are intolerableto standard therapy.
• 4. Patients must have at least one measurable lesion as per RECIST version 1.1.
• 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• 6. Life expectancy ≥ 3 months.
• 7. Patients must have adequate organ function
• 8. Women of child bearing potential (WCBP), defined as a sexually mature woman who hasnot undergone surgical sterilization or who has not been naturally postmenopausal forat least 12 consecutive months must agree to use two effective contraceptive methodswhile on study treatment and for at least twelve weeks after the last dose of the IMP.
• 9. WCBP must have a negative serum pregnancy test within 7 days prior to first dose ofthe IMP.
• 10. Male patients must agree to use a latex condom, even if they had a successfulvasectomy, while on study treatment and for at least twelve weeks after the last doseof the IMP.
• 11. Male patients must agree not to donate sperm, and female patients must agree notto donate eggs, while on study treatment and for at least 12 weeks after the last doseof the IMP.
• 12. Availability of tumor tissue sample at screening.

Exclusion Criteria:

• 1. Prior treatment with any agent that has the same target.
• 2. Central nervous system (CNS) metastasis.
• 3. Active or chronic skin disorder requiring systemic therapy.
• 4. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
• 5. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
• 6. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever isshorter, prior to first dose of the IMP.
• 7. Major surgery within 28 days prior to first dose of the IMP, or no recovery fromside effects of such intervention.
• 8. Significant cardiac disease, such as recent myocardial infarction or acute coronarysyndromes, congestive heart failure， uncontrolled hypertension, uncontrolled cardiacarrhythmias.
• 9. History of thromboembolic or cerebrovascular events, including transient ischemicattacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli withinsix months prior to first dose of the IMP.
• 10. Acute and/or clinically significant bacterial, fungal or viral infection includinghepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
• 11. Administration of a live vaccine within 28 days prior to the administration of thefirst dose of the IMP.