Treatment of advanced liver cancer using MT-303

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, Phase 1 study designed to evaluate the safety and tolerability of MT-303 in adults with advanced hepatocellular carcinoma (HCC) that expresses glypican-3 (GPC3). Participants will receive intravenous administration of MT-303 in sequential dose escalation cohorts to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). The study aims to provide insights into the drug's efficacy and safety profile in this specific patient population.

Why it matters

Who can join: the full rules

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 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's running

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

Study contacts

• Study coordinator: Project Manager
• Email: Lucy.FrereScott@novotech-cro.com
• Phone: +61 2 8569 1400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.