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

NCT ID: NCT05262530

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-28
• Study Completion Date: 2025-12-22

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BNT142

Group Type: EXPERIMENTAL

BNT142

Intervention Type: BIOLOGICAL

Intravenous bolus/infusion

Interventions

BNT142

Intravenous bolus/infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Exclusion Criteria

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.

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioNTech SE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BioNTech Responsible Person

Role: STUDY_DIRECTOR

BioNTech SE

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

South Texas Accelerated Research Therapeutics (START) - San Antonio

San Antonio, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

National University Cancer Institute - National University Hospital

Singapore, , Singapore

HM Nou Delfos General Hospital

Barcelona, , Spain

Hospital Universitario Vall D'Hebron

Barcelona, , Spain

MD Anderson Cancer Center

Madrid, , Spain

START Madrid-FJD Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Hospital Universitario 12 de Octubre - Centro de Actividades Ambulatorias

Madrid, , Spain

START Madrid CIOCC Hospital Universitario HM Sanchinarro

Madrid, , Spain

Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos

Málaga, , Spain

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, , United Kingdom

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

London, , United Kingdom

Churchill Hospital - Oxford University Hospitals NHS Foundation Trust

Oxford, , United Kingdom

Countries

United States; Singapore; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38776391 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37592303 (View on PubMed)

Other Identifiers

2021-005481-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2024-512639-58-00

Identifier Type: CTIS

Identifier Source: secondary_id

BNT142-01

Identifier Type: -

Identifier Source: org_study_id