NCT06478693RecruitingPhase 1
A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC
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
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 24 Jun 2024
- Start date
- Jul 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- Myeloid Therapeutics
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06478693
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 70
- From Jul 2024 to the primary completion date, Dec 2027
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Alfred Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Murdoch | Australia | Recruiting |
| St Vincent's Hospital Coordinator of this site? Confirm its status | Sydney | Australia | Recruiting |
| Integrated Clinical Oncology Network (ICON) Pty Ltd Coordinator of this site? Confirm its status | Woolloongabba | Australia | Recruiting |
| Pusan National Univesity Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Recruiting |
| Cha University Bundang Medical Center Coordinator of this site? Confirm its status | Gyeonggi-do | South Korea | Recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Taipei Tzu Chi Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.