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

Eligibility Criteria

• * 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 laboratory testing using a validated immunohistochemistry (IHC) 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).
• * 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 (NOS) 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 \[NCI\] guidelines) and cancers of unknown primary, not included in the pre-defined eligible tumor types. Patients must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the US 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 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.