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NCT05262530
Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors
Phase 1, PHASE2 trial testing BNT142 in Solid Tumor in 73 participants. Terminated before completion.
22 December 2025
Quick facts
| Lead sponsor | BioNTech SE |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 22 March 2022 |
| Primary completion | 22 December 2025 |
| Estimated completion | 22 December 2025 |
| Sites | 18 locations across Singapore, United Kingdom, United States, Spain |
Drugs / interventions tested
- BNT142 — full drug profile →
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
Sponsor
BioNTech SE — full company profile →
Who can join
18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is an open-label, multicenter, Phase I/IIa, dose escalation, safety, and pharmacokinetics (PK) study of BNT142 followed by expansion cohorts in patients with Claudin 6 (CLDN6)-positive advanced tumors.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Progress and prospects of mRNA-based drugs in pre-clinical and clinical applications.
Shi Y, Shi M, Wang Y, You J. · · 2024 · cited 67× · PMID 39543114 · DOI 10.1038/s41392-024-02002-z -
Nanoparticle technology for mRNA: Delivery strategy, clinical application and developmental landscape.
Li X, Qi J, Wang J, Hu W, et al · · 2024 · cited 47× · PMID 38169577 · DOI 10.7150/thno.84291 -
Optimized lipid nanoparticles (LNPs) for organ-selective nucleic acids delivery <i>in vivo</i>.
Zhang T, Yin H, Li Y, Yang H, et al · · 2024 · cited 42× · PMID 38770138 · DOI 10.1016/j.isci.2024.109804 -
Targeted Cancer Immunotherapy: Nanoformulation Engineering and Clinical Translation.
Yu M, Yang W, Yue W, Chen Y. · · 2022 · cited 35× · PMID 36257824 · DOI 10.1002/advs.202204335 -
mRNA-Based Therapeutics in Cancer Treatment.
Sun H, Zhang Y, Wang G, Yang W, et al · · 2023 · cited 33× · PMID 36839944 · DOI 10.3390/pharmaceutics15020622 -
Preclinical efficacy and pharmacokinetics of an RNA-encoded T cell-engaging bispecific antibody targeting human claudin 6.
Stadler CR, Ellinghaus U, Fischer L, Bähr-Mahmud H, et al · · 2024 · cited 32× · PMID 38776391 · DOI 10.1126/scitranslmed.adl2720 -
Clinical development of therapeutic mRNA applications.
Żak MM, Zangi L. · · 2025 · cited 28× · PMID 40143545 · DOI 10.1016/j.ymthe.2025.03.034 -
Stepping forward: T-cell redirecting bispecific antibodies in cancer therapy.
Qin X, Ning W, Liu H, Liu X, et al · · 2024 · cited 28× · PMID 38828136 · DOI 10.1016/j.apsb.2024.03.027
Verify or expand the search:
- PubMed search for NCT05262530
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other BioNTech SE trials
Trials by the same sponsor.
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- NCT06821061 — A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People · Phase 1, PHASE2 · completed
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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 NCT05262530 (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 BioNTech SE
- Last refreshed: 8 April 2026
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/NCT05262530.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing