Phase I/II Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors
This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.
• 1\. Patients must be willing and able to understand and sign the ICF, and to adhere to the 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 radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to 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 has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months must agree to use two effective contraceptive methods while 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 of the IMP.
• 10\. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP.
• 11\. 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.
• 12\. Availability of tumor tissue sample at screening.