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NCT05220098

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

Terminated Phase 1, PHASE2 Last updated 29 August 2025
What this trial tests

Phase 1, PHASE2 trial testing TAK-280 in Unresectable Locally Advanced or Metastatic Cancer in 69 participants. Terminated before completion.

Timeline
22 April 2022
Primary endpoint
28 July 2025
28 July 2025

Quick facts

Lead sponsorTakeda
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment69
Start date22 April 2022
Primary completion28 July 2025
Estimated completion28 July 2025
Sites23 locations across Canada, United States, Australia, Spain

Drugs / interventions tested

Conditions studied

Sponsor

Takeda — full company profile →

Who can join

18 and older, any sex, with Unresectable Locally Advanced or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Exploiting protease activation for therapy.
    Bleuez C, Koch WF, Urbach C, Hollfelder F, et al · · 2022 · cited 27× · PMID 35314338 · DOI 10.1016/j.drudis.2022.03.011
  2. Prodrug-based bispecific antibodies for cancer therapy: advances and future directions.
    Ai Z, Wang B, Song Y, Cheng P, et al · · 2025 · cited 15× · PMID 39911391 · DOI 10.3389/fimmu.2025.1523693
  3. Engineering a tumor-selective prodrug T-cell engager bispecific antibody for safer immunotherapy.
    McCue AC, Demarest SJ, Froning KJ, Hickey MJ, et al · · 2024 · cited 9× · PMID 38962811 · DOI 10.1080/19420862.2024.2373325
  4. Research progress of B7-H3 in malignant tumors.
    Zhao S, Zhang H, Shang G. · · 2025 · cited 6× · PMID 40519928 · DOI 10.3389/fimmu.2025.1586759
  5. Application and future prospects of bispecific antibodies in the treatment of non-small cell lung cancer.
    Wen J, Cui W, Yin X, Chen Y, et al · · 2025 · cited 5× · PMID 40192238 · DOI 10.20892/j.issn.2095-3941.2024.0470
  6. Adopting tomorrow's therapies today: a perspective review of adoptive cell therapy in lung cancer.
    Abodunrin F, Olson DJ, Emehinola O, Bestvina CM. · · 2025 · cited 5× · PMID 40012708 · DOI 10.1177/17588359251320280
  7. Current landscape of T-cell engagers in early-phase clinical development in solid cancers.
    Spinazzola A, Iannantuono GM, Gulley JL, Giudice E, et al · · 2025 · cited 3× · PMID 41122165 · DOI 10.3389/fimmu.2025.1665838
  8. Reprogramming the Tumor Immune Microenvironment with ICAM-1-Targeted Antibody‒Drug Conjugates and B7-H3-CD3 Bispecific Antibodies.
    Zhou S, Hong M, Zhao D, Li W, et al · · 2025 · cited 3× · PMID 39996528 · DOI 10.1002/advs.202415577

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