Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors
NCT ID: NCT07334119
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2026-01-31
2028-03-30
Brief Summary
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* 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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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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MT-304 Monotherapy
Participants receive MT-304 administered intravenously once every 14 days (Q14D) in escalating dose levels.
MT-304
Safety, tolerability, and pharmacokinetics will be evaluated.
MT-304 + Nivolumab Combination Therapy
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).
MT-304 + Nivolumab
Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.
Interventions
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MT-304
Safety, tolerability, and pharmacokinetics will be evaluated.
MT-304 + Nivolumab
Combination therapy begins after monotherapy dose clearance by the Safety Review Committee.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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CREATE Medicines
UNKNOWN
Myeloid Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Matthew Maurer, MD
Role: STUDY_DIRECTOR
Myeloid Therapeutics
Locations
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Calvary Mater Newcastle
Waratah, New South Wales, Australia
Scientia Clinical Research Ltd
Randwick, New South Wales (nsw), Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Kerrie Cornall
Role: primary
Role: primary
Other Identifiers
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MTX-HER2-304
Identifier Type: -
Identifier Source: org_study_id
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