NCT07334119RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 25 Nov 2025
- Primary completion date
- 31 Jan 2027
- Lead sponsor
- Myeloid Therapeutics
- Diseases
- Bladder cancer, Endometrial cancer, Lung cancer, Colorectal cancer, Liver and biliary tract cancer, Ovarian cancer
- NCT number
- NCT07334119
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 60
- From 25 Nov 2025 to the primary completion date, 31 Jan 2027
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active autoimmune disease not related to prior therapy for primary malignancy that has required systemic therapy in the last 1 year.
Other illness
- 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.
Other
- Known active CNS metastasis and/or carcinomatous meningitis.
- Uncontrolled pleural effusion, pericardial effusion, or ascites
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Research SA Pty Ltd Coordinator of this site? Confirm its status | Adelaide | Australia | Recruiting |
| The Kinghorn Cancer Centre Coordinator of this site? Confirm its status | Darlinghurst | Australia | Recruiting |
| Cabrini Health Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Recruiting |
| Scientia Clinical Research Ltd Coordinator of this site? Confirm its status | Randwick | Australia | Recruiting |
| Icon Cancer Centre South Brisbane Coordinator of this site? Confirm its status | South Brisbane | Australia | Recruiting |
| Calvary Mater Newcastle Coordinator of this site? Confirm its status | Waratah | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.