OverviewStudy detailsEligibilityThings to knowResearchStudy plan
info
Simplify with AI

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.

Study details:

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.

Eligibility criteria

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

Inclusion criteria

  1. Aged 18 years or older
  2. 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]
  3. Measurable lesion per RECIST 1.1 criteria
  4. Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
  5. Child-Pugh score: Class A
  6. Adequate organ function

Exclusion criteria

  1. Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis.
  2. Any acute illness including active infection
  3. History of liver transplantation or on waiting list
  4. Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding
  5. Uncontrolled pleural effusion, pericardial effusion, or ascites
  6. History of symptomatic congestive heart failure
  7. History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    PHASE1

trial

Study ID

NCT06478693

Intervention or treatment

DRUG: MT-303

Conditions

  • Hepatocellular Carcinoma

  • Condition: Hepatocellular Carcinoma

  • DRUG: MT-303

  • Sydney, New South Wales, Australia and more

  • Sponsor: Myeloid Therapeutics

Save

Share

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

Research sites nearby

Closest Location:

St Vincent's Hospital

Select from list below to view details:

  • St Vincent's Hospital

    Sydney, New South Wales, Australia

  • Integrated Clinical Oncology Network (ICON) Pty Ltd

    Woolloongabba, Queensland, Australia

  • The Alfred Hospital

    Melbourne, Victoria, Australia

  • Linear Clinical Research

    Murdoch, Western Australia, Australia

Loading map...

Who is running the clinical trial?

MT

Myeloid Therapeutics

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/ArmIntervention/Treatment
EXPERIMENTAL: MT-303
  • Participants will receive MT-303 through intravenous infusion.
Drug: 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

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      Type, incidence and severity of Adverse EventsSafety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0Up 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 data28 days from the last dose of IMP
      Change from baseline in vital signsTemperature, weight, height, pulse rate and blood pressure will be assessedUp to 30 days from the last dose of IMP
      Change in laboratory parametersHematology, chemistry, coagulation, virology and urine analysis will be assessed.Up to 30 days from the last dose of IMP
      Change from baseline in ECG parametersNot SpecifiedScreening, Day 1 and Day 15

      Secondary Outcome

      MeasureDescriptionTime Frame
      To assess the pharmacokinetics (PK) of MT-303PK parameter: Plasma concentrationsDay 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
      To assess the pharmacokinetics (PK) of MT-303PK parameter: Area under CurveDay 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
      To assess the pharmacokinetics (PK) of MT-303PK 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-303PK 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-303PK 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-303PK 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-303PK 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 reactionNot Specifiedupto 2 years from the last dose of IMP
      To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)Not SpecifiedUp 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 SpecifiedUp to 2 years from the last dose of IMP
      To assess adverse events of special interest (AESI) by measuring hypersensitivity reactionNot SpecifiedUp to 2 years from the last dose of IMP
      To assess adverse events of special interest (AESI) by checking for second primary malignancyNot Specifiedupto 2 years from the last dose of IMP
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

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

      Other trials to consider

      Loading suggested trials...

      Top searched conditions

      Breast CancerLung CancerType 2 DiabetesDermatitisAlzheimersParkinsonsLupusCrohn’s DiseaseAsthmaHypertensionCOPDMultiple SclerosisOsteoarthritisHIV/AIDSPsoriasisStrokeObesityProstate CancerDepressionCardiovascular