Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MT-304, MT-304 + Nivolumab.
- Who it may be relevant to
- Registry conditions: HER2-Expressing Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Drug MT-304
Safety, tolerability, and pharmacokinetics will be evaluated. - Drug MT-304 + Nivolumab
Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.
Primary outcome measures
- Type, incidence and severity of Adverse Events [Time frame: 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) [Time frame: Up to 30 days from the last dose of IMP]
- Number of Participants With Abnormal Clinical Laboratory Parameters (Composite Safety Outcome) [Time frame: Up to 30 days from the last dose of IMP]
- 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.]
- Maximum Tolerated Dose (MTD) [Time frame: 28 days from the last dose of IMP]
- Optimal Biological Dose (OBD) [Time frame: 28 days from the last dose of IMP]
Secondary outcome measures (12)
- 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)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Australia · 7 centers
- The Kinghorn Cancer Centre — Darlinghurst
- Scientia Clinical Research Ltd — Randwick
- Calvary Mater Newcastle — Waratah
- Icon Cancer Centre South Brisbane — South Brisbane
- Cancer Research SA Pty Ltd — Adelaide
- Cabrini Health — Melbourne
- Linear Clinical Research — Nedlands
Identifiers
NCT: NCT07334119 · MTX-HER2-304