Treatment of advanced liver cancer using MT-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
PHASE1 · Myeloid Therapeutics · NCT06478693
This study is testing a new treatment called MT-303 for adults with advanced liver cancer to see if it is safe and how well it works.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Myeloid Therapeutics (industry) |
| Drugs / interventions | atezolizumab, bevacizumab |
| Locations | 9 sites (Sydney, New South Wales and 8 other locations) |
| Trial ID | NCT06478693 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 years or older with advanced or metastatic hepatocellular carcinoma expressing GPC3.
Not a fit: Patients with active central nervous system metastasis or those with severe autoimmune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced liver cancer.
How similar studies have performed: Other studies targeting GPC3 in cancer treatment have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Sydney, New South Wales and 8 other locations
- 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)
- Seoul National University Hospital — Seoul, South Korea (RECRUITING)
- National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
- Taipei Tzu Chi Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Project Manager
- Email: Lucy.FrereScott@novotech-cro.com
- Phone: +61 2 8569 1400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepatocellular Carcinoma, Liver Cancer, Glypican-3, Chimeric antigen receptor, CAR-M