EUCTR2019-003593-17-DE进行中（未招募）1 期
Phase 1/2a, first-in-human, open-label, dose-escalation trial with expansion cohorts to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of BNT411 as a monotherapy in patients with solid tumors and in combination with atezolizumab, carboplatin and etoposide in patients with chemotherapy-naïve extensive-stage small cell lung cancer (ES-SCLC)
适应症
相关药物
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
- 90
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 Part 1A:
- •Histologically confirmed solid tumor (cytology is allowed for non small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and pancreatic cancer) that is metastatic or unresectable and for which there is no available standard therapy likely to confer clinical benefit, or patients who are not candidates for such available therapy.
- •For Part 1B:
- •Histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC)(per the Veterans Administration Lung Study Group [VALG] staging system) who received no prior chemotherapy for extensive stage disease.
- •Those treated with prior chemo/radiotherapy with curative intent for limited stage small cell lung cancer (LS-SCLC) should be treatment-free for at least 6 months since last chemo/radiotherapy.
- •No interstitial lung disease or active, non-infectious pneumonitis.
- •For Both Part 1A and Part 1B
- •Male and female = 18 years of age.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- •Measurable disease according to RECIST 1.1.
- •Adequate hematologic, coagulation, renal and hepatic functions.
- •Please refer to the protocol for a full list of inclusion criteria.
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •Has received prior systemic therapy with a TLR7 agonist.
- •Has been receiving: radiotherapy, chemotherapy, or molecularly-targeted agents or tyrosine kinase inhibitors within 2 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; any live vaccine within 4 weeks of the start of trial treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment.
- •Receives concurrent systemic (oral or intravenous) steroid therapy >10 mg prednisone daily or its equivalent for an underlying condition.
- •Receives concurrent strong inhibitors or inducers of the cytochrome P450 enzymes.
- •Has had major surgery within the 4 weeks before the first dose of BNT411
- •Has ongoing or active infection requiring intravenous treatment with anti-infective therapy that has been administered less than two weeks prior to first dose of trial treatment.
- •Has side effects of any prior therapy or procedures for any medical condition not recovered to NCI CTCAE v.5 Grade =1
- •Has any contraindication to atezolizumab, carboplatin or etoposide as per USPI or SmPC in Part 1B.
- •Please refer to the protocol for a full list of exclusion criteria.
研究者
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