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

Phase 1

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: MT-303

• Registration Number: NCT06478693
• Lead Sponsor: Myeloid Therapeutics

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-24
• Study First Posted: 2024-06-27
• Study Start: 2024-07-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-07-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
MT-303	MT-303	Participants will receive MT-303 through intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Type, incidence and severity of Adverse Events	Up to 2 years from the last dose of Investigational Medicinal Product (IMP)	Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Change from baseline in ECG parameters	Screening, Day 1 and Day 15
Recommended Phase 2 Dose (RP2D)	28 days from the last dose of IMP	The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Change from baseline in vital signs	Up to 30 days from the last dose of IMP	Temperature, weight, height, pulse rate and blood pressure will be assessed
Change in laboratory parameters	Up to 30 days from the last dose of IMP	Hematology, chemistry, coagulation, virology and urine analysis will be assessed.

Secondary Outcome Measures

Name	Time	Method
To assess the pharmacokinetics (PK) of MT-303	Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP	PK parameter: terminal rate constant (λz)
To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)	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)	Up to 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring infusion reaction	upto 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction	Up to 2 years from the last dose of IMP
To assess adverse events of special interest (AESI) by checking for second primary malignancy	upto 2 years from the last dose of IMP

Trial Locations

Locations (7)

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

Pusan National Univesity Hospital; 🇰🇷 Busan, Korea, Republic of

Cha University Bundang Medical Center; 🇰🇷 Gyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of