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

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

Treatments tested in this trial

MT-303
MT-303 +Atezolizumab + Bevacizumab

Treatment groups

70 Participants

are divided into 2 treatment groups

Sponsors and collaborators

Myeloid Therapeutics

Lead sponsor

CREATE Medicines

Collaborator

Source ClinicalTrials.gov