Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06478693

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

Led by Myeloid Therapeutics · Updated on 2025-12-18

70

Participants Needed

9

Research Sites

204 weeks

Total Duration

On this page

Sponsors

M

Myeloid Therapeutics

Lead Sponsor

C

CREATE Medicines

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 years or older
  • Diagnosis of advanced, recurrent, metastatic, or unresectable hepatocellular carcinoma (HCC)
  • Measurable tumor lesion by RECIST 1.1 criteria
  • ECOG performance status of 0 or 1
  • Child-Pugh Class A liver function
  • Adequate organ function
  • For Module 1, participants with other GPC3-expressing tumors may be considered after medical review
  • Only participants with HCC eligible for Module 2
Not Eligible

You will not qualify if you...

  • Active central nervous system metastases or carcinomatous meningitis
  • Any acute illness including active infection
  • History of liver transplantation or on transplant waiting list
  • Untreated or incompletely treated varices with bleeding risk
  • Uncontrolled pleural, pericardial effusion, or ascites
  • History of symptomatic congestive heart failure
  • Severe autoimmune or immune-mediated disease requiring steroids or immunosuppressants within the past year
  • For Module 2: fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
  • Significant cardiovascular disease
  • Severe hypersensitivity to atezolizumab or bevacizumab
  • History of idiopathic pulmonary fibrosis
  • Prior hypertensive crisis or encephalopathy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

St Vincent's Hospital

Sydney, New South Wales, Australia, 2010

Actively Recruiting

2

Integrated Clinical Oncology Network (ICON) Pty Ltd

Woolloongabba, Queensland, Australia, 4102

Actively Recruiting

3

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Actively Recruiting

4

Linear Clinical Research

Murdoch, Western Australia, Australia, 6150

Actively Recruiting

5

Pusan National Univesity Hospital

Busan, South Korea

Actively Recruiting

6

Cha University Bundang Medical Center

Gyeonggi-do, South Korea

Actively Recruiting

7

Seoul National University Hospital

Seoul, South Korea

Actively Recruiting

8

National Taiwan University Hospital

Taipei, Taiwan

Actively Recruiting

9

Taipei Tzu Chi Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

P

Project Manager

CONTACT

C

Clinical Department

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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