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 2147714, New South Wales 2155400, Australia
Integrated Clinical Oncology Network (ICON) Pty Ltd
Woolloongabba 6943568, Queensland 2152274, Australia
The Alfred Hospital
Melbourne 2158177, Victoria 2145234, Australia
Linear Clinical Research
Murdoch 8349091, Western Australia 2058645, Australia
Pusan National Univesity Hospital
Busan 1838524, South Korea
Cha University Bundang Medical Center
Gyeonggi-do 6363696, South Korea
Seoul National University Hospital
Seoul 1835848, South Korea
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