Actively Recruiting
Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
Led by Myeloid Therapeutics · Updated on 2026-05-01
60
Participants Needed
6
Research Sites
122 weeks
Total Duration
On this page
Sponsors
M
Myeloid Therapeutics
Lead Sponsor
C
CREATE Medicines
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or above
- Histologically confirmed diagnosis of metastatic or advanced epithelial cancer expressing HER2
- Measurable lesion per RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
- Adequate organ function
You will not qualify if you...
- 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 current pneumonitis/interstitial lung disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites
- Active autoimmune disease not related to prior therapy for primary malignancy that required systemic therapy in the last 1 year
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Actively Recruiting
2
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
3
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, Australia, 4101
Actively Recruiting
4
Cancer Research SA Pty Ltd
Adelaide, South Australia, Australia, 5000
Actively Recruiting
5
Cabrini Health
Melbourne, Victoria, Australia, 3144
Actively Recruiting
6
Linear Clinical Research
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
Research Team
P
Project Manager
CONTACT
C
Clinical Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here