A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC

Recruiting now · Phase 1

Conditions studied: Hepatocellular Carcinoma

In brief

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 alone (Module 1) and in combination with Atezo/Bev (Module 2) in participants with advanced hepatocellular carcinoma expressing GPC3.

Key facts

Study ID

NCT06478693

Run by

Myeloid Therapeutics

People needed

70

Starts

2024-07-01

Expected to finish

2028-05-31

Last updated by the study team

2025-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 for Module 1 pending a discussion with the Medical Monitor. Only participants with HCC are eligible for Module 2.
• 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
• General Exclusion Criteria
• Known active 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.
• Additional Module 2 Exclusion Criteria:
• Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
• Significant cardiovascular disease
• History of severe hypersensitivity to atezolizumab and/or bevacizumab.
• History of idiopathic pulmonary fibrosis
• Prior history of hypertensive crisis or hypertensive encephalopathy.

Where it is running

• St Vincent's Hospital — Sydney, New South Wales, Australia (enrolling)
• Integrated Clinical Oncology Network (ICON) Pty Ltd — Woolloongabba, Queensland, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• Linear Clinical Research — Murdoch, Western Australia, Australia (enrolling)
• Pusan National Univesity Hospital — Busan, South Korea (enrolling)
• Cha University Bundang Medical Center — Gyeonggi-do, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• National Taiwan University Hospital — Taipei, Taiwan (enrolling)
• Taipei Tzu Chi Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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