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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Tanabe Pharma America, Inc.
Study ID
NCT06943521
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MT-4561 — DRUG
    i.v.

Study Details

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.

Key Dates

First listed
Apr 24, 2025
Start date
Apr 18, 2025
Status verified
Dec 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1 (Dose-escalation)
    Intravenous (IV) infusion of MT-4561 once every week in 28-day cycle, until disease progression or discontinuation criteria are met.

Primary Outcome Measure

Incidence of Adverse Event, Dose limiting toxicities (DLTs) [ Time Frame: a 28-day cycle ]

Central Contacts

  • Clinical Trials Information Desk, to prevent miscommunication,
    Please E-mail
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
University of Southern CaliforniaLos AngelesCalifornia90033-
START MidwestGrand RapidsMichigan49546-
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-

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By research site
University of Southern California· Los Angeles, CASTART Midwest· Grand Rapids, MIThe James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive Cancer Center· Columbus, OHThe University of Texas MD Anderson Cancer Center· Houston, TX

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