NL-OMON53910尚未招募2 期
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 - BNT142-01 (4781/0029)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- BioNTech SE
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •For both parts:
- •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 IHC assay (CLAUDENTIFY®6 IHC-Assay) in formalin-fixed
- •paraffin-embedded (FFPE) 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.
- •The CLAUDENTIFY®6 IHC-Assay test is intended for use as a semi-quantitative
- •immunohistochemistry assay for specific detection of CLDN6 protein expression
- •in FFPE neoplastic tissues. The test results of scored tumor staining intensity
- •and percentage of stained tumor cells present, will be used as a pre-screening
- •test to identify patients with CLDN6-expressing positive tumors.
- •Measurable disease per RECIST 1.1 (measurable per RECIST 1.1 or evaluable per
- •Gynecologic Cancer Intergroup [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
- •patients with NOS tumors (as confirmed by histological diagnosis), rare tumors
- •(defined as those occurring in <15 out of 100,000 people each year as per NCI
- •guidelines) and CUP, 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 form 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 SOC therapy prior to enrollment.
- •For Part 2 (Expansion):
- •Expansion Cohort 1: CLDN6-positive ovarian (including fallopian tube and
- •peritoneal) cancer patients who have received at least one systemic treatment
- •regimen for advanced/metastatic disease with radiographic disease progression
- •on or after last prior treatment and who are not eligible for SOC therapy at
- •the discretion of the investigator.
- •Expansion Cohort 2: CLDN6-positive non-squamous NSCLC who have received at
- •least one prior systemic treatment regimen for advanced/metastatic disease with
- •radiographic disease progression on or after last prior treatment and who are
- •not eligible for SOC therapy at the discretion of the investigator.
- •Expansion Cohort 3: CLDN6-positive testicular cancer patients who have
- •received at least one systemic treatment regimen for advanced/metastatic
- •disease with radiographic disease progression on or after last prior treatment
- •and who are not eligible for SOC therapy at the discretion of the investigator.
- •Note: Patients are considered as not eligible for SOC therapy if in the opinion
- •of the investigator, e.g., there is no effective SOC therapy available, SOC is
- •contraindicated or patient has refused SOC treatment.
排除标准
- •Patients who meet any of the following exclusion criteria will not be eligible
- •for trial entry:
- •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.
- •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 nontarget 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
- •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 (NCI-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.
- •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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