NCT06478693

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

A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Myeloid Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 alone (Module 1) and in combination with Atezo/Bev (Module 2) in participants with advanced hepatocellular carcinoma expressing GPC3.

Detailed description

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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	MT-303	MT-303
DRUG	MT-303 +Atezolizumab + Bevacizumab	MT-303 in combination with Atezo/Bev

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-12-31
• Completion: 2028-05-31
• First posted: 2024-06-27
• Last updated: 2025-12-18

Locations

9 sites across 3 countries: Australia, South Korea, Taiwan