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

December 11, 2025 updated by: Myeloid Therapeutics

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Participants will be enrolled into one of two treatment modules:

  • Module 1 (Monotherapy): Participants will receive MT-303.
  • Module 2 (Combination therapy): Participants will receive MT-303 in combination with atezolizumab + bevacizumab (Atezo/Bev).

In Module 1 (Monotherapy), participants will receive MT-303 across five dose-escalation cohorts and in Module 2 (Combination therapy), participants will receive MT-303 in combination with Atezo/Bev across five dose-escalation cohorts.

Additional cohorts in both modules may be scheduled based on emerging safety and PK data.

Participants will be sequentially enrolled into Cohorts 1 through 5. Both modules will be enrolled concurrently, with Module 2 dosing beginning at one dose level below the known safe dose in Module 1. Safety Review Committee decisions will be informed by all available safety data from Modules 1 and 2.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital
        • Contact:
          • Hao-Wen Sim, MD
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • Integrated Clinical Oncology Network (ICON) Pty Ltd
        • Contact:
          • Vladimir Andelkovic, MD
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Recruiting
        • The Alfred Hospital
        • Contact:
          • Stuart Roberts, MD
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Linear Clinical Research
        • Contact:
          • Tim Humphries, MD
  • South Korea
      • Busan, South Korea
        • Recruiting
        • Pusan National Univesity Hospital
        • Contact:
          • Jeong Heo, MD
      • Gyeonggi-do, South Korea
        • Recruiting
        • CHA University Bundang Medical Center
        • Contact:
          • Hongjae Jeoon, MD
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Yoon Jun Kim, MD
  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
          • Chih-hung Hsu
      • Taipei, Taiwan
        • Recruiting
        • Taipei Tzu Chi Hospital
        • Contact:
          • Her-shyong Shiah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MT-303
Participants will receive MT-303 through intravenous infusion.
Drug: MT-303
MT-303
Experimental: MT-303 + Atezolizumab + Bevacizumab
Participants will receive MT-303 in combination with Atezo/Bev through intravenous infusion.
Drug: MT-303 +Atezolizumab + Bevacizumab
MT-303 in combination with Atezo/Bev

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recommended Phase 2 Dose (RP2D)
Time Frame: 28 days from the last dose of IMP
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
28 days from the last dose of IMP
Change from baseline in ECG parameters
Time Frame: Screening, Day 1 and Day 15
Screening, Day 1 and Day 15
Type, incidence and severity of Adverse Events
Time Frame: 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
Up to 2 years from the last dose of Investigational Medicinal Product (IMP)
Change from baseline in vital signs
Time Frame: Up to 30 days from the last dose of IMP
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
Time Frame: Up to 30 days from the last dose of IMP
Hematology, chemistry, coagulation, virology and urine analysis will be assessed.
Up to 30 days from the last dose of IMP
Optimal Biological dose (OBD)
Time Frame: 21 days from the last dose of IMP
The OBD will be determined using dose limiting toxicities (DLTs) and all other available study data
21 days from the last dose of IMP

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To assess adverse events of special interest (AESI) by measuring infusion reaction
Time Frame: upto 2 years from the last dose of IMP
upto 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)
Time Frame: Up to 2 years from the last dose of IMP
Up to 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring immune effector cell-associated neurotoxicity syndrome (ICANS)
Time Frame: Up to 2 years from the last dose of IMP
Up to 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction
Time Frame: Up to 2 years from the last dose of IMP
Up to 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by checking for second primary malignancy
Time Frame: upto 2 years from the last dose of IMP
upto 2 years from the last dose of IMP
Pharmacokinetics (PK)
Time Frame: 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.
PK parameter: Plasma concentrations
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)
Time Frame: 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.
PK parameter: Area under Curve
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)
Time Frame: 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.
PK parameter: Time of maximum observed plasma concentration (tmax)
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)
Time Frame: 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.
PK parameter: Plasma Clearance (CL)
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)
Time Frame: 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.
PK parameter: Volume of Distribution (Vd)
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)
Time Frame: 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.
PK parameter: Mean residence time (MRT)
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)
Time Frame: 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.
PK parameter: terminal rate constant (λz)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Myeloid Therapeutics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
CREATE Medicines

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Matthew Maurer, MD, Myeloid Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MTX-GPC3-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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