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NCT05220098
First-in-Human Study of TAK-280 in Participants With Solid Tumors
Phase 1, PHASE2 trial testing TAK-280 in Unresectable Locally Advanced or Metastatic Cancer in 69 participants. Terminated before completion.
28 July 2025
Quick facts
| Lead sponsor | Takeda |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 69 |
| Start date | 22 April 2022 |
| Primary completion | 28 July 2025 |
| Estimated completion | 28 July 2025 |
| Sites | 23 locations across Canada, United States, Australia, Spain |
Drugs / interventions tested
- TAK-280 — full drug profile →
Conditions studied
- Unresectable Locally Advanced or Metastatic Cancer — all drugs for Unresectable Locally Advanced or Metastatic Cancer →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT05220098
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05220098 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Takeda
- Last refreshed: 29 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05220098.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing