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New drug TAK-280 aims to fight advanced cancers that resist standard care

NCT ID NCT05220098

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This study tests an experimental drug called TAK-280 in people with advanced cancer that cannot be removed by surgery or has spread to other parts of the body, and who have not responded to or cannot tolerate standard treatments. The main goals are to check the drug's safety and how well it works. Participants receive TAK-280 through an IV for up to 14 cycles, each lasting 28 days, and are followed for about a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TAK-280
What this could lead to
If successful, this could offer a new treatment option for people with advanced cancers that no longer respond to standard therapies.
What could go wrong
This is an early-phase trial with a small number of participants, so the drug may not prove effective or may cause significant side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

69 people

The number who actually took part.

Started

Apr 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Age greater than or equal to (\>=)18 years or \>= the local legal age of majority, as applicable. * 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 * History of known autoimmune disease. * 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.

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Conditions

The condition(s) this trial relates to.

Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Unresectable locally advanced or metastatic cancer

Contacts and locations

Locations

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Cabrini Health

    Malvern, 3144, Australia

  • Centre Hospitalier Universitaire de Sherbrooke CHUS

    Sherbrooke, J1H 5N4, Canada

  • Centre Intégré de Cancérologie du CHU de Québec - Université Laval

    Québec, G1J 1Z4, Canada

  • Chris O'Brien Lifehouse Hospital

    Camperdown, New South Wales, 2050, Australia

  • Duke Cancer Institute

    Durham, North Carolina, 27710, United States

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Quironsalud Barcelona, NEXT Oncology

    Barcelona, 08023, Spain

  • Hospital Universitari Dexeus - Grupo Quironsalud

    Barcelona, 08028, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010, Spain

  • Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON

    Barcelona, 08035, Spain

  • Monash Medical Centre

    Clayton, 3168, Australia

  • SCRI Tennessee Oncology Nashville

    Nashville, Tennessee, 37203, United States

  • START MADRID_Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040, Spain

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104-8805, United States

  • Southern Oncology Clinical Research Unit

    Bedford Park, 5042, Australia

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195-0001, United States

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Arkansas For Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Minnesota - Masonic Cancer Center

    Minneapolis, Minnesota, 55455, United States