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

Last updated: February 3, 2025
Sponsor: Myeloid Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Liver Cancer

Liver Disease

Digestive System Neoplasms

Treatment

MT-303

Clinical Study ID

NCT06478693
MTX-GPC3-303
  • Ages > 18
  • All Genders

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 in participants with advanced hepatocellular carcinoma expressing GPC3.

Eligibility Criteria

Inclusion

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 pending a discussion with the Medical Monitor]

  • 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

Exclusion Criteria

  • Known active central nervous system (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.

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: MT-303
Phase: 1
Study Start date:
July 01, 2024
Estimated Completion Date:
May 31, 2026

Study Description

MT-303 will be administered intravenously with treatment provided until lack of tolerability or progression. Participants will be enrolled in sequential dose escalation cohorts with determination of dose limiting toxicities with the goal of establishing the (maximum tolerated dose) MTD and (Recommended Phase 2 dose) RP2D.

Connect with a study center

  • St Vincent's Hospital

    Sydney, New South Wales 2010
    Australia

    Active - Recruiting

  • Integrated Clinical Oncology Network (ICON) Pty Ltd

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Linear Clinical Research

    Murdoch, Western Australia 6150
    Australia

    Active - Recruiting

  • Pusan National Univesity Hospital

    Busan,
    Korea, Republic of

    Active - Recruiting

  • Cha University Bundang Medical Center

    Gyeonggi-do,
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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