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Clinical Trials in South Korea / NCT06478693
Recruiting Phase 1

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

NCT06478693 · tracked via the Priya Life Science South Korea tracker
Sponsor
Myeloid Therapeutics
Phase
Phase 1
Started
2024-07-01
Last updated
2025-12-18

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

MT-303MT-303 +Atezolizumab + BevacizumabAll Atezolizumab trials (175) →All Bevacizumab trials (436) →

MT-303: MT-303

MT-303 +Atezolizumab + Bevacizumab: MT-303 in combination with Atezo/Bev

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Type, incidence and severity of Adverse Events — Up to 2 years from the last dose of Investigational Medicinal Product (IMP)
    Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
  • Recommended Phase 2 Dose (RP2D) — 28 days from the last dose of IMP
    The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
  • Optimal Biological dose (OBD) — 21 days from the last dose of IMP
    The OBD will be determined using dose limiting toxicities (DLTs) and all other available study data
  • Change from baseline in vital signs — Up to 30 days from the last dose of IMP
    Temperature, weight, height, pulse rate and blood pressure will be assessed
  • Change in laboratory parameters — Up to 30 days from the last dose of IMP
    Hematology, chemistry, coagulation, virology and urine analysis will be assessed.
  • Change from baseline in ECG parameters — Screening, Day 1 and Day 15

Trial sites (9)

FacilityCityRegionStatus
St Vincent's Hospital Sydney New South Wales Recruiting
Integrated Clinical Oncology Network (ICON) Pty Ltd Woolloongabba Queensland Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Linear Clinical Research Murdoch Western 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

Other trials for the same condition

A Phase II Single-Arm Clinical Study to Evaluate the Efficacy and Safety of Carbon Ion Radiotherapy With Atezolizumab and Bevacizumab Combination Therapy in Patients With Advanced Hepatocellular Carcinoma Recruiting
Immunogenomic Dynamics and Biomarkers in Patients With Hepatocellular Carcinoma Receiving Immunotherapy Recruiting
A Study to Evaluate the Safety, Tolerability and Efficacy of RZ-001 with Valganciclovir (VGCV) in Subjects with Hepatocellular Carcinoma Active, not recruiting
Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 Recruiting
Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06478693 on ClinicalTrials.gov ↗ ← All trials in South Korea