Safety and preliminary efficacy trial of BNT142 in patients with CLDN6-positive advanced ovarian, lung, or testicular cancer

Phase 1

Recruiting

• Conditions: MedDRA version: 21.0Level: LLTClassification code: 10043302Term: Testicular cancer Class: 10029104; MedDRA version: 21.0Level: PTClassification code: 10014733Term: Endometrial cancer Class: 100000004864; MedDRA version: 21.1Level: LLTClassification code: 10065143Term: Malignant solid tumour Class: 10029104; Solid Tumors; MedDRA version: 21.1Level: PTClassification code: 10061873Term: Non-small cell lung cancer Class: 100000004864; MedDRA version: 21.0Level: LLTClassification code: 10007460Term: Carcinoma of unknown primary Class: 10029104; MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512639-58-00
• Lead Sponsor: BioNTech SE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-14
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

For both parts: Histological or cytological documentation of a solid tumor that is metastatic or unrespectable provided as a pathology report., CLDN6-positive tumor sample as assessed by central laboratory testing using a Validated immunohistochemistry (IHC) assay (CLAUDENTIFY®6 IHC-Assay) in formalin-fixed paraffin-embedded (FFPE) neoplastic tissues or alternatively from fresh tissue if archival tissue is unavailable, 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 cancer (including fallopian tube and peritoneal), 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, rare tumors and cancer of unknown primary (CUP), not included in the predefined eligible tumor types. Patients must have received all available standard therapies, including targeted therapies based on mutation status, and failed at least first line standard of care (SOC) therapy prior to enrollment

Exclusion Criteria

Prior and concomitant therapy: 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 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)., 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 intravenous (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 (CTCAE 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., Medical conditions Current evidence of new or growing brain or leptomeningeal metastases during screening. Patients with known brain metastases may be ligible if they: i. Had radiotherapy, surgery or stereotactic surgery for the brain metastases; ii. Have no neurological symptoms (excluding Grade =2 neuropathy); iii. Have stable brain metastasis on the Computerized Tomography (CT) or Magnetic Resonance Imaging (MRI) scan within 4 weeks before signing the Informed Consent Form (ICF) iv. Are not undergoing acute corticosteroid therapy or steroid taper., Pregnant or breastfeeding or planning to get pregnant within 6 months of the last dose of BNT142.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified