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A Study of MT-4561 in Patients With Various Advanced Solid Tumors

ConditionsHead and Neck Squamous Cell Carcinoma (HNSCC)Non-small Cell Lung Cancer (NSCLC)Esophageal CancerGastric CancerBiliary Tract CancerPancreatic Ductal Adenocarcinoma (PDAC)Breast CancerOvarian CancerCervical CancerEndometrial CancerProstate CancerUrothelial CarcinomaNeuroendocrine Tumor (NET)Neuroendocrine Carcinoma (NEC)Soft Tissue SarcomaNuclear Protein in Testis (NUT) Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTanabe Pharma America, Inc.

About this trial

This is a First In Human (FIH), multicenter, open-label, Phase I/II study to evaluate safety, tolerability, Pharmacokinetics (PK), pharmacodynamics, and efficacy of MT-4561 in patients with advanced solid tumors. This study will be conducted in 3 parts.

Part 1 is aimed at evaluating safety, tolerability, PK and pharmacodynamics of MT-4561 and determining the Maximum Tolerated Dose (MTD) using the Bayesian Optimal Interval (BOIN) design.

The study details and doses of Part 2 (dose-optimization) and Part 3 (Drug-Drug Interaction) will be available after review of applicable Part 1 results.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female patient aged 18 years or older at the time of signing the informed consent form

≥ 1 measurable lesion by the RECIST v1.1

Eastern Cooperative Oncology Group (ECOG) performance status: 0 to 1

Life expectancy of at least 3 months

Disqualifiers

Patients with active brain or leptomeningeal metastases

Any unresolved toxicity ≥ Grade 2 from previous anticancer therapy except for alopecia

Prior systemic anticancer therapy within 4 weeks before first dose of investigational medicinal product (IMP) or 5 half-lives, whichever is shorter, and prior radiotherapy within 2 weeks before first dose of IMP

History of congenital long QT syndrome or clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation or Torsades de pointes)

Trial design

Design model

Single group

Treatments tested in this trial

  • MT-4561

    Drug

    i.v.

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: Part 1 (Dose-escalation)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Event, Dose limiting toxicities (DLTs)

Part 1 Frequency, duration, and severity (Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) of adverse events, dose limiting toxicity (DLT), physical examinations, changes in clinical laboratory values (e.g., hematology, chemistry, and urinalysis), vital signs (e.g., heart rate, blood pressure, respiratory rate), electrocardiogram DLTs are defined as any event meeting the DLT criteria at least possibly related to MT-4561 for Cycle 1 (i.e., DLT monitoring window is approximately 28 days). Events with a clear alternative explanation will not be considered DLTs.

Time frame
a 28-day cycle
2

Number of Patients with Adverse events (AEs)

Part 1 Frequency, duration, and severity (Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0) of adverse events, dose limiting toxicity (DLT), physical examinations, changes in clinical laboratory values (e.g., hematology, chemistry, and urinalysis), vital signs (e.g., heart rate, blood pressure, respiratory rate), electrocardiogram Adverse event: An AE is defined as any untoward medical occurrence in a clinical study patient administered a pharmaceutical product, and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of an IMP, whether it is considered related to the IMP.

Time frame
Screening through 30 days after last dose

Secondary outcomes

1

Cmax of MT-4561

To determine the pharmacokinetics(PK) profile of MT-4561

Time frame
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
2

time corresponding to occurrence of Cmax (tmax)

To determine the pharmacokinetics(PK) profile of MT-4561

Time frame
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
3

minimum observed plasma concentration (Cmin)

To determine the pharmacokinetics(PK) profile of MT-4561

Time frame
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)
4

area under the concentration-time curve from zero up to 168 hours post-dose (AUC0-168)

To determine the pharmacokinetics(PK) profile of MT-4561

Time frame
Cycle 1 Day 1 through Cycle 2 Day 22 (each cycle is 28 days)

Other outcomes

Sponsors and contacts

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

Tanabe Pharma America, Inc.

Lead sponsor

Source ClinicalTrials.gov
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