This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation studydesigned to assess the safety, tolerability and define the RP2D of MT-303 in participantswith advanced hepatocellular carcinoma expressing GPC3.
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.
Drug: MT-303
MT-303
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.
St Vincent's Hospital
Sydney, New South Wales, Australia
Integrated Clinical Oncology Network (ICON) Pty Ltd
Woolloongabba, Queensland, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Murdoch, Western Australia, Australia
Pusan National Univesity Hospital
Busan, Korea, Republic of
Cha University Bundang Medical Center
Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Project Manager
+61 2 8569 1400
Lucy.FrereScott@novotech-cro.com
Clinical Department
+1 617 465 1022
303clinical@myeloidtx.com
Matthew Maurer, MD, Study Director
Myeloid Therapeutics