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

  • STATUS
    Recruiting
  • End date
    Apr 29, 2026
  • participants needed
    216
  • sponsor
    BioNTech SE
Updated on 29 October 2022

Summary

This trial is an open-label, multicenter, Phase I/IIa, dose escalation, safety, and pharmacokinetics (PK) trial of BNT142 followed by expansion cohorts in patients with Claudin 6 (CLDN6)-positive advanced tumors.

Details
Condition Solid Tumor
Treatment BNT142
Clinical Study IdentifierNCT05262530
SponsorBioNTech SE
Last Modified on29 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

For Part 1 and 2
Histological or cytological documentation of a solid tumor that is metastatic or unresectable via a pathology report
CLDN6-positive tumor sample as assessed by central testing using a validated immunohistochemistry (IHC) assay in formalin-fixed paraffin-embedded (FFPE) neoplastic tissues. FFPE tissue can be derived from fresh biopsies and archival samples. 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, non-squamous non-small cell lung cancer (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 (NOS) tumors not included in the eligible tumor types, including rare tumors and cancers of unknown primary, 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 Food and Drug Administration (FDA), American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO) or local guidelines used at the site), and failed at least first line standard of care (SOC) therapy prior to enrollment

Exclusion Criteria

Radiotherapy, chemotherapy, or molecularly-targeted agents within 3 weeks or 5 half-lives (whichever is longer) of the start of trial treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of trial treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment
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 monoclonal antibody
Side effects of any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5 Grade ≤1, with the exception of alopecia, anorexia, vitiligo, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy. Anorexia, hyperthyroidism, hypothyroidism, and peripheral neuropathy 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 (ICF); and
Are not undergoing acute corticosteroid therapy or steroid taper
Notes: Patients with central nervous system (CNS) 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
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