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

Myeloid Therapeutics

Status and phase: Enrolling; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: MT-303

Study type: Interventional

Funder types: Industry

Identifiers

NCT06478693

MTX-GPC3-303

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 1 patient group

MT-303

Experimental group

Description:

Participants will receive MT-303 through intravenous infusion.

Treatment:

Drug: MT-303