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Unresectable Locally Advanced or Metastatic CancerPhase 1/2NCT05220098

First-in-Human Study of TAK-280 in Participants With Solid Tumors

A Phase 1/2 study testing TAK-280 in people with Unresectable Locally Advanced or Metastatic Cancer, run by Takeda at 23 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failure or are intolerant to standard therapies. Participants will be treated with TAK-280 for up to 14 treatment cycles. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TAK-280
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
23 sitesin 4 countries
Study dates
21 Apr 2022to 28 Jul 2025
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

23 sites in 4 countries.

23 sites in 4 countries

United States10 sites

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195-0001

  • Duke Cancer Institute

    Durham, North Carolina, 27710

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Arkansas For Medical Sciences

    Little Rock, Arkansas, 72205

  • Froedtert and The Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota - Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • SCRI Tennessee Oncology Nashville

    Nashville, Tennessee, 37203

  • University of California San Francisco

    San Francisco, California, 94143

  • Sanford Cancer Center

    Sioux Falls, South Dakota, 57104-8805

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

Other trials in United States

Spain7 sites

  • Hospital Quironsalud Barcelona, NEXT Oncology

    Barcelona, 08023

  • Hospital Universitari Dexeus - Grupo Quironsalud

    Barcelona, 08028

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

    Barcelona, 08035

  • START MADRID_Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

Australia4 sites

  • Southern Oncology Clinical Research Unit

    Bedford Park, 5042

  • Chris O'Brien Lifehouse Hospital

    Camperdown, New South Wales, 2050

  • Monash Medical Centre

    Clayton, 3168

  • Cabrini Health

    Malvern, 3144

Other trials in Australia

Canada2 sites

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

    Québec, G1J 1Z4

  • Centre Hospitalier Universitaire de Sherbrooke CHUS

    Sherbrooke, J1H 5N4

Other trials in Canada

About this study

Official title: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer

The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failure or are intolerant to standard therapies.

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.

Read the detailed description

This study consists of 2 phases: Dose-escalation and cohort-expansion phase.

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.

Being tested
TAK-280
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAK-280Drug

    Participants will receive TAK-280 as IV infusion.

Study groups in NCT05220098
Study groupRoleWhat they receive
Dose-escalation Phase: TAK-280ExperimentalParticipants 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.
Receives: Drug: TAK-280
Cohort-expansion Phase: TAK-280 High or low DoseExperimentalParticipants 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.
Receives: Drug: TAK-280

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Dose Limiting Toxicities (DLTs)

    DLTs were evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0, except cytokine release syndrome (CRS), which was graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Grading for CRS.

    Measured: Cycle 1 (Cycle length=28 days)

  2. Number of Participants With One or More Treatment-emergent Adverse Events (TEAEs)

    An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. A TEAE was defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of new anticancer therapy. AEs were evaluated according to NCI CTCAE, Version 5.0 except CRS, which was graded according to ASTCT Consensus Grading for CRS.

    Measured: From start of study drug administration up to follow-up (up to 37 weeks)

Secondary outcomes (19)

  1. Maximum Observed Plasma Concentration (Cmax) of TAK-280

    Cmax for TAK-280 was reported.

    Measured: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)

  2. Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) of TAK- 280

    AUC0-last for TAK-280 was reported.

    Measured: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)

  3. Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of TAK-280

    AUC0-inf for TAK-280 was reported.

    Measured: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) of TAK-280

    Tmax for TAK-280 was reported.

    Measured: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)

  5. Terminal Disposition Phase Half-Life (t1/2) of TAK-280

    T1/2 was reported.

    Measured: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)

  6. Total Clearance (CL) of TAK-280

    CL of TAK-280 was reported.

    Measured: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)

  7. Volume of Distribution at Steady State (Vss) After IV Administration of TAK-280

    Vss of TAK-280 was reported.

    Measured: Cycles 1-7: Pre-dose and post-dose up to 48 hours on Days 1, 2, 3, 8, 15 and 22 (Cycle length= 28 days)

  8. Overall Response Rate (ORR)

    ORR was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Working Group 3 (PCWG3) as defined by the Investigator based on radiologic criteria. ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) as per RECIST version 1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeter (mm). PR: At least a 30 percentage (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 37 weeks

  9. Duration of Response (DOR)

    The DOR was assessed according to RECIST version 1.1. and defined as time from the date of first documentation of a PR or better to the date of the first documentation of progressive disease (PD) or death due to any cause, whichever occurred first, for participants with a confirmed response (PR or better). CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: Up to 37 weeks

  10. Progression Free Survival (PFS)

    PFS was assessed according to RECIST version 1.1 and was defined as the time from the date of first dose of TAK-280 to the date of first documentation of PD or death due to any cause, whichever occurred first. PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum diameters while on study.

    Measured: Up to 37 weeks

  11. Overall Survival (OS)

    OS was defined as the time from the date of first dose TAK-280 until death due to any cause.

    Measured: Up to 37 weeks

  12. Disease Control Rate (DCR)

    DCR was defined as the percentage of participants who achieved PR, CR, or stable disease (SD) with a duration of >=2 consecutive scans determined by the investigator as per RECIST v1.1. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

    Measured: Up to 37 weeks

  13. Number of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response

    PSA response was defined as a reduction in baseline PSA level of greater than or equal to (>=) 50% maintained for at least 3 weeks in participants with mCRPC.

    Measured: Up to 37 weeks

  14. Duration of PSA Response in Participants With mCRPC

    Duration of PSA response was the time from the date of the first PSA response to the date of the first documented PSA progression in participants with mCRPC.

    Measured: Up to 37 weeks

  15. Time to PSA Progression in Participants With mCRPC

    Time to PSA progression was the time from the date of the first dose of TAK-280 to the date that an increase of 25% or more and absolute increase of 2 ng/mL or more from the nadir in participants with mCRPC.

    Measured: Up to 37 weeks

  16. Percentage of Participants With PSA Reductions of >=50% at 6 Months

    PSA response was defined as a reduction in baseline PSA level of >=50% maintained for at 6 months in participants with mCRPC.

    Measured: At 6 months

  17. Number of Participants Who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280

    Number of participants who were negative for TAK-280 at baseline and became positive were reported.

    Measured: Up to 37 weeks

  18. Number of Participants Who Developed B7-H3 Targeted Neutralizing Antibodies (NAb) to TAK 280

    Number of participants who developed B7-H3 NAb titers for TAK-280 were reported. TAK-280 is a bispecific T-cell engager with binding specificity for B7-H3 and conditional binding to CD3.

    Measured: Up to 37 weeks

  19. Number of Participants Who Developed CD3 Targeted Neutralizing Antibodies to TAK 280

    Number of participants who developed CD3 NAb titers for TAK-280 were reported. TAK-280 is a bispecific T-cell engager with binding specificity for B7-H3 and conditional binding to CD3.

    Measured: Up to 37 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2022
  2. Study start21 Apr 2022
  3. Primary completion28 Jul 2025
  4. Study completion28 Jul 2025

Why it stopped: Terminated due to limited anti-cancer activity

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Dose-escalation Phase is non-randomized and Cohort-expansion Phase will include randomized and non-randomized cohorts.
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05220098
Sponsor's protocol ID
TAK-280-1501
Other IDs
2023-504012-16-00, 2023
Status last verified
Jun 2026
First submitted
7 Jan 2022
Last updated
7 Jul 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TAK-280 in people with Unresectable Locally Advanced or Metastatic Cancer, run by Takeda at 23 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Spain, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Dose Limiting Toxicities (DLTs) (time frame: Cycle 1 (Cycle length=28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05220098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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