About this trial
This is a first-in-human, open-label, multicenter Phase Ia/Ib study of AMT- 676, followed by an open-label, multicenter, dose-escalation.
Eligibility criteria
Qualifiers
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 pathologically confirmed unresectable advanced solid tumor. Preferred tumor types include colorectal cancer, gastric cancer, esophageal adenocarcinoma, cholangiocarcinoma, pancreatic ductal cancers, and neuroendocrine tumors.
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.
Disqualifiers
Prior treatment with any agent for the same target or ADC based on topoisomerase I inhibitor.
Central nervous system (CNS) metastasis
History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
Trial design
Treatments tested in this trial
- AMT-676