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NCT Number: NCT07334119

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.

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Key information

Conditions

HER2-Expressing Solid Tumors Adenocarcinoma Adenocarcinoma Of Esophagus Adnexal Diseases Biliary Tract Diseases Biliary Tract Neoplasms Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Ovarian Epithelial Carcinoma, Transitional Cell Cholangiocarcinoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Kinghorn Cancer Centre, Darlinghurst, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MT-304

Drug

Safety, tolerability, and pharmacokinetics will be evaluated.

Other names: mRNA-LNP

MT-304 + Nivolumab

Drug

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

Other names: mRNA-LNP

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

Secondary outcomes

  1. 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).

    PK Parameter: Maximum plasma concentration (Cmax)

  2. 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).

    PK parameter: Area under Curve

  3. 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).

    PK parameter: Time of maximum observed plasma concentration (tmax)

  4. 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).

    PK parameter:Terminal half-life (t½)

  5. 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).

    PK parameter: Plasma Clearance (CL)

  6. 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).

    PK parameter: Volume of Distribution (Vd)

  7. 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).

    PK parameter: Mean residence time (MRT)

  8. To assess adverse events of special interest (AESI) by measuring infusion reaction

    Time frame: Upto 90 days from the last dose of IMP

  9. 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

  10. 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

  11. To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction

    Time frame: Upto 90 days from the last dose of IMP

  12. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Department

CONTACT

[email protected]

+16174651022

Project Manager

CONTACT

[email protected]

+61731376255

Sponsors and collaborators

Lead sponsor

Myeloid Therapeutics

Industry

Collaborators

  • CREATE Medicines

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jan 12, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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