NL-OMON53640尚未招募不适用
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 - BNT141-01
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- BioNTech SE
- 入组人数
- 58
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 all parts:
- •Metastatic or unresectable solid tumor.
- •Histological or cytological documentation of a solid tumor via a pathology
- •CLDN18.2-positive tumor sample defined as moderate-to-strong CLDN18.2 protein
- •expression defined as intermediate (2+) to strong (3+) staining intensity in >=
- •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)
- •not be accepted for CLDN18.2 examination. If archival tissue samples from
- •points of time are available, the most recent one is preferred. Patients with a
- •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
- •therapy likely to confer clinical benefit, or the patient is not a candidate
- •available therapy. Patients must have received all available standard therapies
- •failed at least first-line SOC therapy prior to enrolment. Measurable or
- •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-smallcell
- •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.
- •(Page 5 of the protocol)
排除标准
- •Patients who meet at least one of the following exclusion criteria will not be
- •eligible for trial
- •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
- •(excluding BNT141); nitrosoureas, antibody-drug conjugates, or radioactive
- •isotopes within 6 weeks of the start of trial treatment. Palliative
- •radiotherapy will be
- •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
- •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
- •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
- •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.
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