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Solid TumorPhase 1/2NCT05262530

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

A Phase 1/2 study testing BNT142 in people with Solid Tumor, run by BioNTech SE at 18 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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
BNT142
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
18 sitesin 4 countries
Study dates
22 Mar 2022to 22 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
  • For Part 1 and 2:
  • Histological or cytological documentation of a malignant solid tumor (via a pathology report) that is metastatic or unresectable.
  • CLDN6-positive tumor sample as assessed by central laboratory testing using a validated immunohistochemistry assay in formalin-fixed paraffin-embedded neoplastic tissues or alternatively from fresh tissue if archival tissue is unavailable. If archival tissue samples from several points of time are available, the most recent one is preferred.
  • Measurable disease per RECIST 1.1 (measurable per RECIST 1.1 or evaluable per GCIG criteria for ovarian tumors).
  • For Part 1 (Dose escalation):
  • Patients with advanced/metastatic ovarian (including fallopian tube and peritoneal), non-squamous NSCLC, endometrial, or testicular cancer, for whom there is no available standard therapy likely to confer clinical benefit, or the patient is not a candidate for such available therapy, or patients with not otherwise specified tumors (as confirmed by histological diagnosis), rare tumors (defined as those occurring in <15 out of 100,000 people each year as per National Cancer Institute guidelines) and cancers of unknown primary, not included in the pre-defined eligible tumor types (the last three upon approval by the medical monitor). Patients must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the United States Food and Drug Administration [FDA], American Society of Clinical Oncology, European Society for Medical Oncology or local guidelines used at the site), and failed at least first line standard of care therapy prior to enrollment.

Who cannot join

  • Chemotherapy, or molecularly-targeted agents within 3 weeks or 5 half-lives (whichever is longer) of the start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of study treatment.
  • Radiotherapy in the last 6 weeks prior to the first dose of BNT142 (excluding brain radiotherapy for which 3 weeks prior to the first dose of BNT142 is allowed). Previously irradiated tumor lesions cannot be considered as target lesions or non-target lesions in this study.
  • Concurrent systemic (oral or intravenous [IV]) steroid therapy >10 mg prednisone daily or its equivalent for an underlying condition apart from physiologic corticosteroid replacement therapy.
  • Major surgery within 4 weeks before the first dose of BNT142.
  • Ongoing or active infection requiring IV treatment with anti-infective therapy that has been administered less than 2 weeks prior to the first dose of BNT142.
  • Prior treatment with a CLDN6 targeting therapy.
Show all 14Show fewer
  • Side effects of any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events v.5 Grade ≤1, except for anorexia, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to Grade ≤2. Alopecia of any grade is allowed.
  • Current evidence of new or growing brain or leptomeningeal metastases during screening. Patients with known brain metastases may be eligible if they:
  • Had radiotherapy, surgery or stereotactic surgery for the brain metastases;
  • Have no neurological symptoms (excluding Grade ≤2 neuropathy);
  • Have stable brain metastasis on the computer tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the informed consent form; and
  • Are not undergoing acute corticosteroid therapy or steroid taper.
  • Notes: Patients with central nervous system symptoms should undergo a CT scan or MRI of the brain to exclude new or progressive brain metastases. Spinal bone metastases are allowed, unless imminent fracture with cord compression is anticipated.
  • Pregnant or breastfeeding or planning to get pregnant within 6 months of the last dose of BNT142.

Trial locations and contacts

18 sites in 4 countries.

18 sites in 4 countries

Spain7 sites

  • HM Nou Delfos General Hospital

    Barcelona, 08023

  • Hospital Universitario Vall D'Hebron

    Barcelona, 08035

  • MD Anderson Cancer Center

    Madrid, 28033

  • START Madrid-FJD Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario 12 de Octubre - Centro de Actividades Ambulatorias

    Madrid, 28041

  • START Madrid CIOCC Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos

    Málaga, 29010

Other trials in Spain

United States6 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • NEXT Virginia

    Fairfax, Virginia, 22031

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • South Texas Accelerated Research Therapeutics (START) - San Antonio

    San Antonio, Texas, 78229

Other trials in United States

United Kingdom4 sites

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • The Clatterbridge Cancer Centre NHS Foundation Trust

    Liverpool, L7 8YA

  • Hammersmith Hospital, Imperial College School Of Medicine - Imperial College Healthcare NHS Trust

    London, W12 0HS

  • Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 7LE

Other trials in United Kingdom

Singapore1 site

  • National University Cancer Institute - National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

Official title: First-in-human, Open-label, Multicenter, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT142 in Patients With CLDN6-positive Advanced Solid Tumors

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.

Read the detailed description

Part 1 (Dose escalation) of this study is a first-in-human (FIH), open-label, dose escalation safety and PK study of BNT142 in patients with advanced/metastatic CLDN6-positive solid tumors.

Part 2 (Expansion) will be a Phase IIa proof-of-concept study in up to three expansion cohorts of CLDN6 positive advanced/metastatic ovarian cancer, non-small cell lung cancer (NSCLC) of non-squamous type, and testicular cancer patients who have progressed on or after last prior treatment.

Conditions
Solid Tumor
Being tested
BNT142
Keywords
CLDN6-positive solid tumors

What participants receive

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

  • BNT142Biological

    Intravenous bolus/infusion

Study groups in NCT05262530
Study groupRoleWhat they receive
BNT142ExperimentalNot described
Receives: Biological: BNT142

What is being measured

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

  1. Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, serious, or fatal TEAEs by causal relationship to study treatment

    Measured: From first dose to 60 days after the last dose of BNT142

  2. Occurrence of dose reductions and discontinuation of BNT142 due to TEAEs

    Measured: From first dose to 60 days after the last dose of BNT142

  3. Part 1: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period in the dose escalation

    Measured: Assessed during the DLT period, i.e., up to 5 weeks after first dose of BNT142

  4. Part 2: Objective response rate (ORR)

    ORR is defined as the proportion of patients in whom a confirmed complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and per Gynecological Cancer Intergroup (GCIG) criteria incorporating RECIST 1.1 and cancer antigen (CA)-125 for the ovarian cancer population is the best overall response.

    Measured: Up to 36 months after last patient last dose

Secondary outcomes (11)

  1. Part 1: PK parameter: Area under the concentration-time curve in the dosing interval (AUC)

    Measured: Pre-dose until 60 days after last dose

  2. Part 1: PK parameter: Clearance (CL)

    Measured: Pre-dose until 60 days after last dose

  3. Part 1: PK parameter: Volume of distribution (Vd)

    Measured: Pre-dose until 60 days after last dose

  4. Part 1: PK parameter: Maximum observed concentration (Cmax)

    Measured: Pre-dose until 60 days after last dose

  5. Part 1: PK parameter: Time to maximum observed concentration (Tmax)

    Measured: Pre-dose until 60 days after last dose

  6. Part 1: PK parameter: Concentration prior to next dose (Ctrough)

    Measured: Pre-dose until 60 days after last dose

  7. Part 1: PK parameter: Minimum observed concentration (Cmin)

    Measured: Pre-dose until 60 days after last dose

  8. Part 1: PK parameter: Elimination half-life (t½)

    Measured: Pre-dose until 60 days after last dose

  9. Part 1: ORR

    ORR (Part 1 only) is defined as the proportion of patients in whom a confirmed CR or PR, per RECIST 1.1, is the best overall response.

    Measured: Up to 36 months after last patient last dose

  10. Disease control rate (DCR)

    DCR is defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1 [and per GCIG criteria for ovarian cancer patients], SD assessed at least 6 weeks after first dose) as best overall response.

    Measured: Up to 36 months after last patient last dose

  11. Duration of response (DOR)

    DOR is defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (progressive disease per RECIST 1.1) or death from any cause, whichever occurs first.

    Measured: Up to 36 months after last patient last dose

Timeline

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

  1. First posted2 Mar 2022
  2. Study start22 Mar 2022
  3. Primary completion22 Dec 2025
  4. Study completion22 Dec 2025

Why it stopped: Sponsor decision

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262530
Sponsor's protocol ID
BNT142-01
Other IDs
2021-005481-18, 2024-512639-58-00
Status last verified
Apr 2026
First submitted
21 Feb 2022
Last updated
8 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stadler CR, Ellinghaus U, Fischer L, Bahr-Mahmud H, Rao M, Lindemann C, Chaturvedi A, Scharf C, Biermann I, Hebich B, Malz A, Beresin G, Falck G, Hacker A, Houben A, Erdeljan M, Wolf K, Kullmann M, Chang P, Tureci O, Sahin U. Preclinical efficacy and pharmacokinetics of an RNA-encoded T cell-engaging bispecific antibody targeting human claudin 6. Sci Transl Med. 2024 May 22;16(748):eadl2720. doi: 10.1126/scitranslmed.adl2720. Epub 2024 May 22.

    PubMed 38776391

  • Simon AG, Lyu SI, Laible M, Woll S, Tureci O, Sahin U, Alakus H, Fahrig L, Zander T, Buettner R, Bruns CJ, Schroeder W, Gebauer F, Quaas A. The tight junction protein claudin 6 is a potential target for patient-individualized treatment in esophageal and gastric adenocarcinoma and is associated with poor prognosis. J Transl Med. 2023 Aug 17;21(1):552. doi: 10.1186/s12967-023-04433-8.

    PubMed 37592303

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing BNT142 in people with Solid Tumor, run by BioNTech SE at 18 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 7 inclusion and 14 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 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Spain, United States, United Kingdom, Singapore. 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?

The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.

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?

Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, serious, or fatal TEAEs by causal relationship to study treatment (time frame: From first dose to 60 days after the last dose of BNT142). The study lists 4 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 NCT05262530, which also lists 2 linked publications.

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 8 Apr 2026.

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