Overview
This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the RP2D of MT-303 in participants with advanced hepatocellular carcinoma expressing GPC3.
Description
MT-303 will be administered intravenously with treatment provided until lack of tolerability or progression. Participants will be enrolled in sequential dose escalation cohorts with determination of dose limiting toxicities with the goal of establishing the (maximum tolerated dose) MTD and (Recommended Phase 2 dose) RP2D.
Eligibility
Inclusion Criteria
- Aged 18 years or older
- Histological diagnosis of advanced/recurrent or metastatic and/or unresectable HCC. [Note: participants with other tumor types expressing GPC3 may be eligible pending a discussion with the Medical Monitor]
- Measurable lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
- Child-Pugh score: Class A
- Adequate organ function
Exclusion Criteria
- Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis.
- Any acute illness including active infection
- History of liver transplantation or on waiting list
- Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- History of symptomatic congestive heart failure
- History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.