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

PHASE1RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-07-01

Primary completion: 2025-07-31

Study completion finish: 2026-05-31

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06478693

Intervention or treatment

DRUG: MT-303

Conditions

• Hepatocellular Carcinoma

Image related to Hepatocellular Carcinoma

Condition: Hepatocellular Carcinoma
DRUG: MT-303
Sydney, New South Wales, Australia and more
Sponsor: Myeloid Therapeutics

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

St Vincent's Hospital

Research sites nearby

Select from list below to view details:

St Vincent's Hospital
Sydney, New South Wales, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Integrated Clinical Oncology Network (ICON) Pty Ltd
Woolloongabba, Queensland, Australia
Linear Clinical Research
Murdoch, Western Australia, Australia

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?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: MT-303 Participants will receive MT-303 through intravenous infusion.	DRUG: MT-303 MT-303

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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
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	Not Specified	Screening, Day 1 and Day 15

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
To assess the pharmacokinetics (PK) of MT-303	PK parameter: Plasma concentrations	Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
To assess the pharmacokinetics (PK) of MT-303	PK parameter: Area under Curve	Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
To assess the pharmacokinetics (PK) of MT-303	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
To assess the pharmacokinetics (PK) of MT-303	PK parameter: Plasma Clearance (CL)	Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
To assess the pharmacokinetics (PK) of MT-303	PK parameter: Volume of Distribution (Vd)	Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
To assess the pharmacokinetics (PK) of MT-303	PK parameter: Mean residence time (MRT)	Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
To assess the pharmacokinetics (PK) of MT-303	PK parameter: terminal rate constant (λz)	Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
To assess adverse events of special interest (AESI) by measuring infusion reaction	Not Specified	upto 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)	Not Specified	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)	Not Specified	Up to 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction	Not Specified	Up to 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by checking for second primary malignancy	Not Specified	upto 2 years from the last dose of IMP

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

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References

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