Health TrialsbyHealthPanel

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

ConditionHepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMyeloid Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • MT-303

    Drug

    MT-303

  • MT-303 +Atezolizumab + Bevacizumab

    Drug

    MT-303 in combination with Atezo/Bev

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: MT-303Experimental treatment 1 intervention
Group B: MT-303 + Atezolizumab + BevacizumabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Type, incidence and severity of Adverse Events

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

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

Recommended Phase 2 Dose (RP2D)

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

Time frame
28 days from the last dose of IMP
3

Optimal Biological dose (OBD)

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

Time frame
21 days from the last dose of IMP
4

Change from baseline in vital signs

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

Time frame
Up to 30 days from the last dose of IMP

Secondary outcomes

1

Pharmacokinetics (PK)

PK parameter: Plasma concentrations

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.
2

Pharmacokinetics (PK)

PK parameter: Area under Curve

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.
3

Pharmacokinetics (PK)

PK parameter: Time of maximum observed plasma concentration (tmax)

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.
4

Pharmacokinetics (PK)

PK parameter: Plasma Clearance (CL)

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Myeloid Therapeutics

Lead sponsor

CREATE Medicines

Collaborator

Source ClinicalTrials.gov
Apply now