First-in-Human Study of TAK-280 in Participants With Solid Tumors
NCT ID: NCT05220098
Last Updated: 2025-08-29
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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TERMINATED
PHASE1/PHASE2
69 participants
INTERVENTIONAL
2022-04-22
2025-07-28
Brief Summary
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Participants will be treated with TAK-280 for up to 14 treatment cycles. Each treatment cycle will be 28 days.
After the last dose of study drug, participants will be followed up for survival every 12 weeks for a total of 48 weeks.
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Detailed Description
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Dose-escalation phase:
The purpose of the dose-escalation phase is to generate data to characterize the initial safety and tolerability profile of TAK-280 and determine the 2 recommended doses for expansion (RDEs) of TAK-280 to be administered during the cohort-expansion phase.
Cohort-Expansion Phase:
The cohort expansion phase will be conducted in 3 indications. Only in 1 selected indication participants will be randomized 1:1 to receive either TAK-280 high dose or low dose. In the remaining 2 indications to be studied in the cohort-expansion phase, participants will receive only one dose level of TAK-280.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose-escalation Phase: TAK-280
Participants will receive TAK-280 intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
TAK-280
Participants will receive TAK-280 as IV infusion.
Cohort-expansion Phase: TAK-280 High or low Dose
Participants will receive either TAK-280 high or low dose in one selected indication and only one dose level of TAK-280 in the remaining indications as determined from the dose-escalation phase of the study in 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
TAK-280
Participants will receive TAK-280 as IV infusion.
Interventions
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TAK-280
Participants will receive TAK-280 as IV infusion.
Eligibility Criteria
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Inclusion Criteria
* Criteria for disease state in dose escalation and cohort expansion.
1. Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
2. Tumor histologies during cohort expansion: Participants will be eligible if they have histologically proven, unresectable, locally advanced or metastatic malignant neoplasms.
* Eastern Cooperative Oncology Group performance status (less than or equal to \[\<=\]) 1.
* Measurable disease per RECIST V1.1 by investigator except for participants with mCRPC with bone metastases only (these participants are allowed in the study). Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions, unless treatment was \>=6 months prior to start of treatment or there has been demonstrated progression with a clear margin to measure in that particular lesion.
Exclusion Criteria
* Major surgery or traumatic injury within 8 weeks before the first dose of TAK-280.
* Unhealed wounds from surgery or injury.
* Ongoing or active infection of Grade \>=2.
* Oxygen saturation less than (\<) 92 percent (%) on room air at screening or during Cycle 1 Day 1 (C1D1) predose assessment.
* Inflammatory process that has not resolved for \>= 4 weeks before the first dose of study drug. Participants with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of their duration.
* Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
* Known hypersensitivity to TAK-280 or any excipient.
18 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University of Arkansas For Medical Sciences
Little Rock, Arkansas, United States
University of California San Francisco
San Francisco, California, United States
University of Minnesota - Masonic Cancer Center
Minneapolis, Minnesota, United States
Duke Cancer Institute
Durham, North Carolina, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Sanford Cancer Center
Sioux Falls, South Dakota, United States
Avera Cancer Institute
Sioux Falls, South Dakota, United States
SCRI Tennessee Oncology Nashville
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, Australia
Southern Oncology Clinical Research Unit
Bedford Park, , Australia
Monash Medical Centre
Clayton, , Australia
Cabrini Health
Malvern, , Australia
Centre Intégré de Cancérologie du CHU de Québec - Université Laval
Québec, , Canada
Centre Hospitalier Universitaire de Sherbrooke CHUS
Sherbrooke, , Canada
Hospital Quironsalud Barcelona, NEXT Oncology
Barcelona, , Spain
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, , Spain
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, , Spain
START MADRID_Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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2023-504012-16-00
Identifier Type: CTIS
Identifier Source: secondary_id
TAK-280-1501
Identifier Type: -
Identifier Source: org_study_id
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