RecruitingPhase 1NCT07334119

Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors

A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors


Sponsor

Myeloid Therapeutics

Enrollment

60 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Summary

This clinical trial is designed to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of MT-304 in adults with advanced HER2-expressing solid tumors. The main questions it aims to answer are: * What is the safety profile of MT-304 when administered alone or with nivolumab? * What is the recommended Phase 2 dose (RP2D) of MT-304? Participants will: * Receive MT-304 alone (every 14 days) or with nivolumab (every 28 days). * Attend regular clinic visits for assessments and monitoring. * Continue treatment until disease progression, unacceptable toxicity, or study discontinuation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called MT-304 in adults with advanced solid tumors (cancers that have spread) that produce high levels of a protein called HER2. The study is evaluating the drug's safety, how the body processes it, and whether it shows early signs of effectiveness. **You may be eligible if...** - You are 18 or older - You have been diagnosed with a metastatic or advanced cancer that overexpresses HER2 (confirmed by testing) - Your cancer can be measured on imaging scans - Your overall health and organ function are adequate (ECOG 0–1) **You may NOT be eligible if...** - You have active cancer that has spread to the brain - You currently have a fever or acute illness - You have had significant heart failure or serious lung inflammation in the past - You have uncontrolled fluid buildup around the lungs, heart, or in the abdomen - You have an active autoimmune disease requiring systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMT-304

Safety, tolerability, and pharmacokinetics will be evaluated.

DRUGMT-304 + Nivolumab

Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.


Locations(6)

Scientia Clinical Research Ltd

Randwick, New South Wales, Australia

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, Australia

Cancer Research SA Pty Ltd

Adelaide, South Australia, Australia

Cabrini Health

Melbourne, Victoria, Australia

Linear Clinical Research

Nedlands, Western Australia, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07334119