EUCTR2022-001843-25-ES进行中（未招募）1 期
Phase I/IIa, first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT141 as a monotherapy and in combination with other anti-cancer agents in patients with CLDN18.2-positive solid tumors - Safety and preliminary efficacy trial of BNT141 in patients with CLDN18.2-positive solid tumors
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- BioNTech SE
- 入组人数
- 154
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •For all parts:
- •Metastatic or unresectable solid tumor.
- •Histological or cytological documentation of a solid tumor via a pathology report.
- •CLDN18.2-positive tumor sample defined as moderate-to-strong CLDN18.2 protein expression defined as intermediate (2+) to strong (3+) staining intensity in = 50% of tumor cells as assessed by central testing using a CLIA-validated immunohistochemistry assay in formalin-fixed, paraffin-embedded (FFPE) neoplastic tissues. New biopsies and archival bio-samples are allowed. Bone biopsies are not allowed. Cytology specimens (including fine needle aspirates) will not be accepted for CLDN18.2 examination. If archival tissue samples from several points of time are available, the most recent one is preferred. Patients with a lower expression level or with CLDN18.2-negative cancers are not eligible.
- •Trial part-specific inclusion criteria:
- •For Part 1A: Patients with solid tumors, for which there is no available standard therapy likely to confer clinical benefit, or the patient is not a candidate for such available therapy. Patients must have received all available standard therapies and failed at least first-line SOC therapy prior to enrolment. Measurable or evaluable disease per RECIST 1.1. Eligible tumor types are gastric cancer, gastroesophageal junction (GEJ) and esophageal adenocarcinoma, pancreatic, biliary tract (cholangiocarcinoma and gallbladder cancer), and mucinous ovarian cancers.
- •Additionally, patients with specific tumors (including colorectal cancer, non-small cell lung cancer, gastric subtype of endocervical adenocarcinoma) where there is scientific evidence that the CLDN18.2 could be elevated can be tested for CLDN18.2 expression.
- •For Part 1B: Patients with advanced pancreatic adenocarcinoma or cholangiocarcinoma who are eligible for treatment with nab-paclitaxel and gemcitabine. Measurable or evaluable disease per RECIST 1.1.
- •For Part 2 (Expansion):
- •- Cohort 1 – Pancreatic adenocarcinoma: pancreatic adenocarcinoma eligible for treatment with nab-paclitaxel and gemcitabine. Measurable disease per RECIST 1.1.
- •- Cohort 2 – Cholangiocarcinoma: cholangiocarcinoma eligible for treatment with nab-paclitaxel and gemcitabine. Measurable disease per RECIST 1.1.
- •For complete list of inclusion criteria, please refer to the protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •Receiving: 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
- •(excluding BNT141); nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment. Palliative radiotherapy will be allowed.
- •Receives concurrent systemic (oral or intravenous [IV]) steroid therapy > 10 mg prednisone daily or its equivalent for an underlying condition.
- •Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted.
- •Major surgery within 4 weeks before the first dose of BNT141.
- •Prior treatment with a CLDN18.2 targeting mAb other than BNT141.
- •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 BNT141.
- •Side effects of any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for AEs (NCICTCAE) v.5 Grade = 1, with the exception of 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 or leptomeningeal metastases may be eligible if they have:
- •- Radiotherapy, surgery or stereotactic surgery for the brain or leptomeningeal metastases.
- •- No neurological symptoms (excluding Grade = 2 neuropathy).
- •- Stable brain or leptomeningeal disease on the computer tomography (CT) or magnet resonance imaging (MRI) scan within 4 weeks before signing the informed consent form (ICF).
- •- Not undergoing acute corticosteroid therapy or steroid taper.
- •For complete list of exclusion criteria, please refer to the protocol.
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