HER2-Expressing Solid TumorsPhase 1NCT07334119
Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
A Phase 1 study testing MT-304 and MT-304 + Nivolumab in people with HER2-Expressing Solid Tumors, run by Myeloid Therapeutics at 7 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-Expressing Solid Tumors
- What is being tested?
- MT-304 and MT-304 + Nivolumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesAustralia
- Study dates
- 25 Nov 2025to 30 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Australia7 sites, 7 recruiting
- Recruiting
Cancer Research SA Pty Ltd
Adelaide, South Australia, 5000
Dr Meena Okera, +61883592565
Dr Meena Okera
- Recruiting
The Kinghorn Cancer Centre
Darlinghurst, New South Wales, 2010
Dr Rasha Cosman, +61393555655
Dr Rasha Cosman
- Recruiting
Cabrini Health
Melbourne, Victoria, 3144
Dr. Prachi Bhave, +61395083437
Dr. Prachi Bhave
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 6009
Dr Timothy Humphries, +61863825100
Dr Timothy Humphries
- Recruiting
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
Dr Charlotte Lemech, contactus@scientiaclinicalresearch.org.au
Dr Charlotte Lemech
- Recruiting
Icon Cancer Centre South Brisbane
South Brisbane, Queensland, 4101
A/Prof Jermaine Coward, +61737374500
A/Prof Jermaine Coward
- Recruiting
Calvary Mater Newcastle
Waratah, New South Wales, 2298
Kerrie Cornall, +61240143282
Dr Jordan Cohen
About this study
Official title: 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
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.
Read the detailed description
This multicenter, open-label, Phase 1 trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of MT-304 in adults aged 18 and older with advanced HER2-expressing solid tumors.
The study consists of two treatment modules:
- Module 1 (Monotherapy): Participants receive MT-304 every 14 days for 28-day cycles, with dosing adjustments based on clinical benefit and safety evaluations.
- Module 2 (Combination Therapy): Participants receive MT-304 in combination with nivolumab, administered every 14 days and 28 days, respectively, also allowing for dosing adjustments.
The Bayesian Optimal Interval (BOIN) design will guide dose escalation, overseen by a Safety Review Committee to establish the recommended Phase 2 dose (RP2D).
Regular assessments, including vital signs and laboratory tests, will monitor safety and efficacy throughout the trial, with follow-up visits for up to 2 years post-treatment.
- Conditions
- HER2-Expressing Solid Tumors
- Being tested
- MT-304, MT-304 + Nivolumab
- Keywords
- Anti-HER2 chimeric antigen receptor, Chimeric Antigen Receptor (CAR), mRNA, Lipid nanoparticle (LNP), Urothelial carcinoma, Endometrial carcinoma, Ovarian epithelial carcinoma, Breast carcinoma (all subtypes), Gastric adenocarcinoma, Esophageal adenocarcinoma, Non-small cell lung cancer, Colorectal carcinoma, Biliary cancer (including Gallbladder carcinoma and extrahepatic cholangiocarcinoma)
- Medical subject headings
- Carcinoma, Transitional Cell, Endometrial Neoplasms, Carcinoma, Ovarian Epithelial, Breast Neoplasms, Adenocarcinoma Of Esophagus, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-304Drug
Also called mRNA-LNP
Safety, tolerability, and pharmacokinetics will be evaluated.
MT-304 + NivolumabDrug
Also called mRNA-LNP
Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.
| Study group | Role | What they receive |
|---|---|---|
| MT-304 Monotherapy | Experimental | Participants receive MT-304 administered intravenously once every 14 days (Q14D) in escalating dose levels. Receives: Drug: MT-304 |
| MT-304 + Nivolumab Combination Therapy | Experimental | Participants receive MT-304 administered intravenously once every 14 days (Q14D) in combination with nivolumab as "per local label" administered once every 28 days (Q28D). Receives: Drug: MT-304 + Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type, incidence and severity of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.
Measured: 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)
Body temperature, body weight, pulse rate, and blood pressure (systolic and diastolic) assessed collectively; participants with clinically significant changes in any vital sign parameter will be summarized as a composite safety outcome.
Measured: Up to 30 days from the last dose of IMP
Number of Participants With Abnormal Clinical Laboratory Parameters (Composite Safety Outcome)
Hematology, clinical chemistry, coagulation, virology testing, and urinalysis assessed collectively; participants with abnormalities in any laboratory parameter will be summarized as a composite safety outcome.
Measured: Up to 30 days from the last dose of IMP
Number of Participants With Change From Baseline in ECG Parameters (Composite Safety Outcome)
PR interval, QRS duration, QT interval, corrected QT interval (QTc), and heart rate assessed collectively from 12-lead ECG recordings; participants with clinically significant changes in any ECG parameter will be summarized as a composite safety outcome.
Measured: Screening through Day 28, with assessments performed on Screening, Day 1 (pre-dose), and Day 28.
Maximum Tolerated Dose (MTD)
The MTD in Module 1 (monotherapy) will be determined based on dose-limiting toxicities (DLTs).
Measured: 28 days from the last dose of IMP
Optimal Biological Dose (OBD)
The OBD in Module 2 (combination) will be identified based on dose-limiting toxicities (DLTs).
Measured: 28 days from the last dose of IMP
Secondary outcomes (12)
Pharmacokinetics (PK)
PK Parameter: Maximum plasma concentration (Cmax)
Measured: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
PK parameter: Area under Curve
Measured: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
PK parameter: Time of maximum observed plasma concentration (tmax)
Measured: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
PK parameter:Terminal half-life (t½)
Measured: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
PK parameter: Plasma Clearance (CL)
Measured: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
PK parameter: Volume of Distribution (Vd)
Measured: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
PK parameter: Mean residence time (MRT)
Measured: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
To assess adverse events of special interest (AESI) by measuring infusion reaction
Measured: Upto 90 days from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)
Measured: Upto 90 days from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring immune effector cell-associated neurotoxicity syndrome (ICANS)
Measured: Upto 90 days from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction
Measured: Upto 90 days from the last dose of IMP
To assess the incidence of second primary malignancies reported as adverse events of special interest (AESI) occurring during the study treatment period and long-term follow-up.
Measured: From first dose of Investigational Medicinal Product (IMP) through end of study and follow-up (up to 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start25 Nov 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-Expressing Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myeloid Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CREATE Medicines
- Responsible party
- Sponsor
- Investigators
- Matthew Maurer, MD, Study director, Myeloid Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334119
- Sponsor's protocol ID
- MTX-HER2-304
- Status last verified
- Oct 2025
- First submitted
- 14 Nov 2025
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07334119
- Acronym / sponsor ID
- MTX-HER2-304
- Conditions
- HER2-Expressing Solid Tumors
- Keywords
- Anti-HER2 chimeric antigen receptor, Chimeric Antigen Receptor (CAR), mRNA, Lipid nanoparticle (LNP), Urothelial carcinoma, Endometrial carcinoma, Ovarian epithelial carcinoma, Breast carcinoma (all subtypes)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Myeloid TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- CREATE Medicines
- Study start
- 25 Nov 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This multicenter, open-label, Phase 1 trial is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of MT-304 in adults aged 18 and older with advanced HER2-expressing solid tumors.
The study consists of two treatment modules:
- Module 1 (Monotherapy): Participants receive MT-304 every 14 days for 28-day cycles, with dosing adjustments based on clinical benefit and safety evaluations.
- Module 2 (Combination Therapy): Participants receive MT-304 in combination with nivolumab, administered every 14 days and 28 days, respectively, also allowing for dosing adjustments.
The Bayesian Optimal Interval (BOIN) design will guide dose escalation, overseen by a Safety Review Committee to establish the recommended Phase 2 dose (RP2D).
Regular assessments, including vital signs and laboratory tests, will monitor safety and efficacy throughout the trial, with follow-up visits for up to 2 years post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MT-304 Monotherapy | Experimental | Drug: MT-304Participants receive MT-304 administered intravenously once every 14 days (Q14D) in escalating dose levels. |
| MT-304 + Nivolumab Combination Therapy | Experimental | Drug: MT-304 + NivolumabParticipants receive MT-304 administered intravenously once every 14 days (Q14D) in combination with nivolumab as "per local label" administered once every 28 days (Q28D). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-304Also: mRNA-LNPSafety, tolerability, and pharmacokinetics will be evaluated. | Drug | MT-304 Monotherapy |
| MT-304 + NivolumabAlso: mRNA-LNPCombination therapy begins after monotherapy dose clearance by the Safety Review Committee. | Drug | MT-304 + Nivolumab Combination Therapy |
Primary outcome
Type, incidence and severity of Adverse Events
Time frame: Up to 90 days from the last dose of Investigational Medicinal Product (IMP)
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.
Number of Participants With Change From Baseline in Vital Signs (Composite Safety Outcome)
Time frame: Up to 30 days from the last dose of IMP
Body temperature, body weight, pulse rate, and blood pressure (systolic and diastolic) assessed collectively; participants with clinically significant changes in any vital sign parameter will be summarized as a composite safety outcome.
Number of Participants With Abnormal Clinical Laboratory Parameters (Composite Safety Outcome)
Time frame: Up to 30 days from the last dose of IMP
Hematology, clinical chemistry, coagulation, virology testing, and urinalysis assessed collectively; participants with abnormalities in any laboratory parameter will be summarized as a composite safety outcome.
Number of Participants With Change From Baseline in ECG Parameters (Composite Safety Outcome)
Time frame: Screening through Day 28, with assessments performed on Screening, Day 1 (pre-dose), and Day 28.
PR interval, QRS duration, QT interval, corrected QT interval (QTc), and heart rate assessed collectively from 12-lead ECG recordings; participants with clinically significant changes in any ECG parameter will be summarized as a composite safety outcome.
Maximum Tolerated Dose (MTD)
Time frame: 28 days from the last dose of IMP
The MTD in Module 1 (monotherapy) will be determined based on dose-limiting toxicities (DLTs).
Optimal Biological Dose (OBD)
Time frame: 28 days from the last dose of IMP
The OBD in Module 2 (combination) will be identified based on dose-limiting toxicities (DLTs).
12 secondary outcomes
Pharmacokinetics (PK)
Time frame: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
Time frame: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
Time frame: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
Time frame: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
Time frame: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
Time frame: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
Pharmacokinetics (PK)
Time frame: From Day 1, Day 2, Day 8, and Day 15 of Cycles 1 and 2, and Day 1 of Cycle 3 (each cycle is 28 days).
To assess adverse events of special interest (AESI) by measuring infusion reaction
Time frame: Upto 90 days from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)
Time frame: Upto 90 days from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring immune effector cell-associated neurotoxicity syndrome (ICANS)
Time frame: Upto 90 days from the last dose of IMP
To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction
Time frame: Upto 90 days from the last dose of IMP
To assess the incidence of second primary malignancies reported as adverse events of special interest (AESI) occurring during the study treatment period and long-term follow-up.
Time frame: From first dose of Investigational Medicinal Product (IMP) through end of study and follow-up (up to 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Matthew Maurer, MD study director
Myeloid Therapeutics
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT-304 and MT-304 + Nivolumab in people with HER2-Expressing Solid Tumors, run by Myeloid Therapeutics at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Project Manager (+61731376255, MTX-HER2-304_ClinicalStudy@novotech-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type, incidence and severity of Adverse Events (time frame: Up to 90 days from the last dose of Investigational Medicinal Product (IMP)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.