NCT06478693

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_1 hepatocellular-carcinoma

Timeline
25mo left

Started Jul 2024

Typical duration for phase_1 hepatocellular-carcinoma

Geographic Reach
3 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jul 2024May 2028

First Submitted

Initial submission to the registry

June 24, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2028

Last Updated

December 18, 2025

Status Verified

January 1, 2025

Enrollment Period

3.5 years

First QC Date

June 24, 2024

Last Update Submit

December 11, 2025

Conditions

Hepatocellular Carcinoma

Keywords

Liver CancerHepatocellular Carcinoma (HCC)Glypican-3Chimeric antigen receptorCAR-M

Outcome Measures

Primary Outcomes (6)

  • Type, incidence and severity of Adverse Events

    Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0

    Up to 2 years from the last dose of Investigational Medicinal Product (IMP)

  • Recommended Phase 2 Dose (RP2D)

    The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data

    28 days from the last dose of IMP

  • Optimal Biological dose (OBD)

    The OBD will be determined using dose limiting toxicities (DLTs) and all other available study data

    21 days from the last dose of IMP

  • Change from baseline in vital signs

    Temperature, weight, height, pulse rate and blood pressure will be assessed

    Up to 30 days from the last dose of IMP

  • Change in laboratory parameters

    Hematology, chemistry, coagulation, virology and urine analysis will be assessed.

    Up to 30 days from the last dose of IMP

  • Change from baseline in ECG parameters

    Screening, Day 1 and Day 15

Secondary Outcomes (12)

  • Pharmacokinetics (PK)

    Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.

  • Pharmacokinetics (PK)

    Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.

  • Pharmacokinetics (PK)

    Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.

  • Pharmacokinetics (PK)

    Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.

  • Pharmacokinetics (PK)

    Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP for Module 1 and Day 1, 2, 8 and once every 21 days post first dose of IMP for Module 2.

  • +7 more secondary outcomes

Study Arms (2)

MT-303

EXPERIMENTAL

Participants will receive MT-303 through intravenous infusion.

Drug: MT-303

MT-303 + Atezolizumab + Bevacizumab

EXPERIMENTAL

Participants will receive MT-303 in combination with Atezo/Bev through intravenous infusion.

Drug: MT-303 +Atezolizumab + Bevacizumab

Interventions

MT-303DRUG

MT-303

MT-303
MT-303 +Atezolizumab + BevacizumabDRUG

MT-303 in combination with Atezo/Bev

MT-303 + Atezolizumab + Bevacizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

St Vincent's Hospital

Sydney, New South Wales, 2010, Australia

RECRUITING

Integrated Clinical Oncology Network (ICON) Pty Ltd

Woolloongabba, Queensland, 4102, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Linear Clinical Research

Murdoch, Western Australia, 6150, 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

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver NeoplasmsSimpson-Golabi-Behmel syndrome

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Matthew Maurer, MD

    Myeloid Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Project Manager

CONTACT

+61 2 8569 1400Lucy.FrereScott@novotech-cro.com

Clinical Department

CONTACT

+1 617 465 1022303clinical@myeloidtx.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2024

First Posted

June 27, 2024

Study Start

July 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

May 31, 2028

Last Updated

December 18, 2025

Record last verified: 2025-01

Locations

KR(3)AU(4)TW(2)