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NCT05262530

Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors

Terminated Phase 1, PHASE2 Last updated 8 April 2026
What this trial tests

Phase 1, PHASE2 trial testing BNT142 in Solid Tumor in 73 participants. Terminated before completion.

Timeline
22 March 2022
Primary endpoint
22 December 2025
22 December 2025

Quick facts

Lead sponsorBioNTech SE
PhasePhase 1, PHASE2
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment73
Start date22 March 2022
Primary completion22 December 2025
Estimated completion22 December 2025
Sites18 locations across Singapore, United Kingdom, United States, Spain

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. Clinical development of therapeutic mRNA applications.
    Żak MM, Zangi L. · · 2025 · cited 28× · PMID 40143545 · DOI 10.1016/j.ymthe.2025.03.034
  8. 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:

Other recruiting trials for Solid Tumor

Currently open trials in the same condition.

Other BioNTech SE trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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