MTX-GPC3-303
A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including Hepatocellular Carcinoma
Trial summary:
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.
Receptor status / problem studied:
Inclusion criteria
1) Aged 18 years or older.
2) 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]
3) Measurable lesion per RECIST 1.1 criteria.
4) Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1.
5) Child-Pugh score: Class A.
6) Adequate organ function.
Exclusion criteria
1) Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis.
2) Any acute illness including active infection.
3) History of liver transplantation or on waiting list.
4) Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding.
5) Uncontrolled pleural effusion, pericardial effusion, or ascites.
6) History of symptomatic congestive heart failure.
7)History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.
Trial Title
MTX-GPC3-303
Diagnosis
Advanced solid tumours
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
I