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Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT-304 in Adults With Advanced HER2-Expressing Solid Tumors

ConditionHER2-Expressing Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMyeloid Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MT-304

    Drug

    Safety, tolerability, and pharmacokinetics will be evaluated.

  • MT-304 + Nivolumab

    Drug

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: MT-304 MonotherapyExperimental treatment 1 intervention
Group B: MT-304 + Nivolumab Combination TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Type, incidence and severity of Adverse Events

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

Time frame
Up to 90 days from the last dose of Investigational Medicinal Product (IMP)
2

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.

Time frame
Up to 30 days from the last dose of IMP
3

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.

Time frame
Up to 30 days from the last dose of IMP
4

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.

Time frame
Screening through Day 28, with assessments performed on Screening, Day 1 (pre-dose), and Day 28.

Secondary outcomes

1

Pharmacokinetics (PK)

PK Parameter: Maximum plasma concentration (Cmax)

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).
2

Pharmacokinetics (PK)

PK parameter: Area under Curve

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).
3

Pharmacokinetics (PK)

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

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).
4

Pharmacokinetics (PK)

PK parameter:Terminal half-life (t½)

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Myeloid Therapeutics

Lead sponsor

CREATE Medicines

Collaborator

Source ClinicalTrials.gov
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