NCT07334119

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
24mo left

Started Nov 2025

Typical duration for phase_1

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Nov 2025Mar 2028

First Submitted

Initial submission to the registry

November 14, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

November 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

Expected
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

May 1, 2026

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

November 14, 2025

Last Update Submit

April 27, 2026

Conditions

HER2-Expressing Solid Tumors

Keywords

Anti-HER2 chimeric antigen receptorChimeric Antigen Receptor (CAR)mRNALipid nanoparticle (LNP)Urothelial carcinomaEndometrial carcinomaOvarian epithelial carcinomaBreast carcinoma (all subtypes)Gastric adenocarcinomaEsophageal adenocarcinomaNon-small cell lung cancerColorectal carcinomaBiliary cancer (including Gallbladder carcinoma and extrahepatic cholangiocarcinoma)

Outcome Measures

Primary Outcomes (6)

  • Type, incidence and severity of Adverse Events

    Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.

    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.

    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.

    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.

    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).

    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).

    28 days from the last dose of IMP

Secondary Outcomes (12)

  • Pharmacokinetics (PK)

    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)

    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)

    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)

    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)

    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).

  • +7 more secondary outcomes

Study Arms (2)

MT-304 Monotherapy

EXPERIMENTAL

Participants receive MT-304 administered intravenously once every 14 days (Q14D) in escalating dose levels.

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).

Drug: MT-304 + Nivolumab

Interventions

MT-304DRUG

Safety, tolerability, and pharmacokinetics will be evaluated.

Also known as: mRNA-LNP
MT-304 Monotherapy
MT-304 + NivolumabDRUG

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

Also known as: mRNA-LNP
MT-304 + Nivolumab Combination Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Scientia Clinical Research Ltd

Randwick, New South Wales, 2031, Australia

RECRUITING

Calvary Mater Newcastle

Waratah, New South Wales, 2298, Australia

RECRUITING

Icon Cancer Centre South Brisbane

South Brisbane, Queensland, 4101, Australia

RECRUITING

Cancer Research SA Pty Ltd

Adelaide, South Australia, 5000, Australia

RECRUITING

Cabrini Health

Melbourne, Victoria, 3144, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional CellEndometrial NeoplasmsCarcinoma, Ovarian EpithelialBreast NeoplasmsAdenocarcinoma Of EsophagusCarcinoma, Non-Small-Cell LungColorectal NeoplasmsBiliary Tract NeoplasmsCholangiocarcinoma

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesOvarian NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBiliary Tract DiseasesAdenocarcinoma

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Matthew Maurer, MD

    Myeloid Therapeutics

    STUDY DIRECTOR

Central Study Contacts

Project Manager

CONTACT

+61731376255MTX-HER2-304_ClinicalStudy@novotech-cro.com

Clinical Department

CONTACT

+16174651022mt-304.clinical@createmedicines.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

January 12, 2026

Study Start

November 25, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

May 1, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

AU(6)