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

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…

ClinicalTrials.gov IDNCT07334119

PhasePHASE1

Enrollment60

SponsorMyeloid Therapeutics

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

HER2-Expressing Solid Tumors

About this study

Interventions

Drug: MT-304 — Safety, tolerability, and pharmacokinetics will be evaluated.
Drug: MT-304 + Nivolumab — Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.

Primary outcomes

Type, incidence and severity of Adverse Events (Up to 90 days from the last dose of Investigational Medicinal Product (IMP))
Number of Participants With Change From Baseline in Vital Signs (Composite Safety Outcome) (Up to 30 days from the last dose of IMP)
Number of Participants With Abnormal Clinical Laboratory Parameters (Composite Safety Outcome) (Up to 30 days from the last dose of IMP)
Number of Participants With Change From Baseline in ECG Parameters (Composite Safety Outcome) (Screening through Day 28, with assessments performed on Screening, Day 1 (pre-dose), and Day 28.)
Maximum Tolerated Dose (MTD) (28 days from the last dose of IMP)
Optimal Biological Dose (OBD) (28 days from the last dose of IMP)

Eligibility information

Inclusion Criteria: * Aged 18 years or above * Histologically confirmed diagnosis of metastatic or advanced epithelial cancer expressing HER2 (Note: Participants with other tumor types expressing HER2 may be considered pending discussion with the Medical Monitor). * Measurable lesion per RECIST 1.1 criteria. * Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1. * Adequate Organ function Exclusion Criteria: * Known active CNS metastasis and/or carcinomatous meningitis. * Any acute illness including fever. * History of symptomatic congestive heart failure * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease. * Uncontrolled pleural effusion, pericardial effusion, or ascites * Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year.

Study locations

The Kinghorn Cancer Centre, Darlinghurst, New South Wales 2010 Australia
Scientia Clinical Research Ltd, Randwick, New South Wales 2031 Australia
Calvary Mater Newcastle, Waratah, New South Wales 2298 Australia
Icon Cancer Centre South Brisbane, South Brisbane, Queensland 4101 Australia
Cancer Research SA Pty Ltd, Adelaide, South Australia 5000 Australia
Cabrini Health, Melbourne, Victoria 3144 Australia
Linear Clinical Research, Nedlands, Western Australia 6009 Australia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-16.