Hepatocellular CarcinomaPhase 1NCT06478693
A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC
A Phase 1 study testing MT-303 and MT-303 +Atezolizumab + Bevacizumab in people with Hepatocellular Carcinoma, run by Myeloid Therapeutics at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- MT-303 and MT-303 +Atezolizumab + Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 1 Jul 2024to 31 May 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 3 countries
Australia4 sites, 4 recruiting
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 3004
Stuart Roberts, MD
- Recruiting
Linear Clinical Research
Murdoch, Western Australia, 6150
Tim Humphries, MD
- Recruiting
St Vincent's Hospital
Sydney, New South Wales, 2010
Hao-Wen Sim, MD
- Recruiting
Integrated Clinical Oncology Network (ICON) Pty Ltd
Woolloongabba, Queensland, 4102
Vladimir Andelkovic, MD
South Korea3 sites, 3 recruiting
- Recruiting
Pusan National Univesity Hospital
Busan
Jeong Heo, MD
- Recruiting
Cha University Bundang Medical Center
Gyeonggi-do
Hongjae Jeoon, MD
- Recruiting
Seoul National University Hospital
Seoul
Yoon Jun Kim, MD
Taiwan2 sites, 2 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Chih-hung Hsu
- Recruiting
Taipei Tzu Chi Hospital
Taipei
Her-shyong Shiah
About this study
Official title: 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.
Read the 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.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- MT-303, MT-303 +Atezolizumab + Bevacizumab
- Keywords
- Liver Cancer, Hepatocellular Carcinoma (HCC), Glypican-3, Chimeric antigen receptor, CAR-M
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Simpson-Golabi-Behmel syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-303Drug
MT-303
MT-303 +Atezolizumab + BevacizumabDrug
MT-303 in combination with Atezo/Bev
| Study group | Role | What they receive |
|---|---|---|
| MT-303 | Experimental | Participants will receive MT-303 through intravenous infusion. Receives: Drug: MT-303 |
| MT-303 + Atezolizumab + Bevacizumab | Experimental | Participants will receive MT-303 in combination with Atezo/Bev through intravenous infusion. Receives: Drug: MT-303 +Atezolizumab + Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence and severity of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 30 days from the last dose of IMP
Change in laboratory parameters
Hematology, chemistry, coagulation, virology and urine analysis will be assessed.
Measured: Up to 30 days from the last dose of IMP
Change from baseline in ECG parameters
Measured: Screening, Day 1 and Day 15
Secondary outcomes (12)
Pharmacokinetics (PK)
PK parameter: Plasma concentrations
Measured: 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)
PK parameter: Area under Curve
Measured: 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)
PK parameter: Time of maximum observed plasma concentration (tmax)
Measured: 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)
PK parameter: Plasma Clearance (CL)
Measured: 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)
PK parameter: Volume of Distribution (Vd)
Measured: 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)
PK parameter: Mean residence time (MRT)
Measured: 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)
PK parameter: terminal rate constant (λz)
Measured: 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.
To assess adverse events of special interest (AESI) by measuring infusion reaction
Measured: upto 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)
Measured: 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)
Measured: Up to 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction
Measured: Up to 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by checking for second primary malignancy
Measured: upto 2 years from the last dose of IMP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jul 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myeloid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CREATE Medicines
- Responsible party
- Sponsor
- Investigators
- Matthew Maurer, MD, Study director, Myeloid Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478693
- Sponsor's protocol ID
- MTX-GPC3-303
- Status last verified
- Jan 2025
- First submitted
- 24 Jun 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06478693
- Acronym / sponsor ID
- MTX-GPC3-303
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Liver Cancer, Hepatocellular Carcinoma (HCC), Glypican-3, Chimeric antigen receptor, CAR-M
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Myeloid TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- CREATE Medicines
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT-303 | Experimental | Drug: MT-303Participants will receive MT-303 through intravenous infusion. |
| MT-303 + Atezolizumab + Bevacizumab | Experimental | Drug: MT-303 +Atezolizumab + BevacizumabParticipants will receive MT-303 in combination with Atezo/Bev through intravenous infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-303MT-303 | Drug | MT-303 |
| MT-303 +Atezolizumab + BevacizumabMT-303 in combination with Atezo/Bev | Drug | MT-303 + Atezolizumab + Bevacizumab |
Primary outcome
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
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
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
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
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.
Change from baseline in ECG parameters
Time frame: Screening, Day 1 and Day 15
12 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
To assess adverse events of special interest (AESI) by measuring infusion reaction
Time frame: 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
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
To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Maurer, MD study director
Myeloid Therapeutics
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-303 and MT-303 +Atezolizumab + Bevacizumab in people with Hepatocellular Carcinoma, run by Myeloid Therapeutics at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+61 2 8569 1400, Lucy.FrereScott@novotech-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, incidence and severity of Adverse Events (time frame: Up to 2 years from the last dose of Investigational Medicinal Product (IMP)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.