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Safety and preliminary efficacy trial of BNT142 in patients with CLDN6-positive advanced ovarian, lung, or testicular cancer
EU CTIS ID: 2024-512639-58-00
What this study is testing
For Parts 1 and 2: To assess the safety and tolerability of BNT142 at all dose levels tested. For Part 1: To identify the MAD/MTD/RP2D of BNT142 based on the occurrence of DLTs using the following definitions: The maximum tolerated dose (MTD) is defined as the highest tolerated dose where less than 1/3 patients experience a dose-limiting toxicity (DLT). The maximum administered dose (MAD) is defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The Response Evaluation Criteria in Solid Tumors (RP2D) will be defined based on integrated evaluation of safety, tolerability, clinical benefit, Pharmacokinetics, and Pharmacodynamics data from all dose levels tested. For Part 2: To evaluate the anti-tumor activity of BNT142 according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and for ovarian cancer patients according to definitions for response and progression in ovarian cancer clinical trials incorporating RECIST 1.1 and cancer antigen-125 (CA) by the Gynecological Cancer Intergroup (GCIG).
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Singapore
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Singapore; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.