NL-OMON47909已完成不适用
Phase Ib, open-label, multi-center study to characterize the safety, tolerability and pharmacodynamics (PD) of PDR001 in combination with LCL161, everolimus (RAD001) or panobinostat (LBH589) (CPDR001X2102) - CPDR001X2102
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 43
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 64（—）
入选标准
- •Female and male patients >= 18 years old.
- •Subjects, who have progressed despite standard therapy or are intolerant to
- •standard therapy, or for whom no standard therapy exists. Diagnosis CRC, NSCLC,
- •TNBC, TP53 wt CRC and TP53 wt RCC.
- •See protocol page 39 for details.
- •ECOG performance status 0-1.
- •Disease amenable to biopsy and a candidate for tumor biopsy according to the
- •treating institution*s guidelines. Patient must be willing to undergo a new
- •tumor biopsy at baseline, and during therapy on this study.
- •Prior therapy with PD-1/PDL-1 inhibitors is allowed. See protocol page 40 for
排除标准
- •History of severe hypersensitivity reactions to other monoclonal antibodies
- •Patients with known hypersensitivity to any of the components of
- •investigational treatment will be excluded from participation in the
- •corresponding arm. Patients that have a history of hypersensitivity to
- •rapamycin derivatives will be excluded from participation in the everolimus arm
- •History of or current drug-induced interstitial lung disease or pneumonitis
- •grade >=2
- •Symptomatic CNS metastases or CNS metastases that require local CNS-directed
- •therapy or increasing doses of corticosteroids within the prior 2 weeks.
- •Out of range laboratory values. See protocol page 40 for details. Impaired
- •cardiac function or clinically significant cardiac disease. See protocol page
- •40 for details.
- •Active autoimmune disease, infection requiring antibiotics.
- •HBV or HCV infection. Known HIV infection. See protocol page 41 for details.
- •Systemic anti-cancer therapy within 2 weeks of the first dose of study
- •treatment. See protocol page 41 for details.
- •Treatment with systemic steroid therapy, other than in the setting of adrenal
- •insufficiency, systemic immunosuppressive therapy.
- •Life vaccines against infectious diseases within 4 weeks of initiation of
- •study treatment.
- •Major surgery within 2 weeks. See protocol page 41 for details.
- •Radiotherapy within 2 weeks, except for palliative radiotherapy to a limited
- •CSF within 3 weeks. See protocol page 41 for details.
- •Pregnancy, lactation, insufficient contraception for females of childbearing
研究者
相似试验
招募中
不适用
A Phase I/IIa open-label, multi-center study to evaluate the safety, tolerability, whole-body distribution, radiation dosimetry and anti-tumor activity of [177Lu]-NeoB administered in patients with advanced solid tumors known to overexpress gastrin-releasing peptide receptor (GRPR)Advanced solid tumors known to overexpress GRPRAdvanced solid tumorsgastrin-releasing peptide receptor10027655NL-OMON54819Advanced Accelerator Applications International SA10
招募中
2 期
NeoRay - Phase I/IIa trial of [177Lu]-NeoB in patients with advanced solid tumors and with [68Ga]-NeoB lesion uptake.2023-507170-41-00Advanced Accelerator Applications International S.A., Advanced Accelerator Applications International S.A.9
进行中（未招募）
1 期
eoRay - Phase I/IIa trial of [177Lu]-NeoB in patients with advanced solid tumors and with [68Ga]-NeoB lesion uptake.Solid tumors known to overexpress GRPR and with [68Ga]-NeoB lesion uptakeEUCTR2018-004727-37-GBAdvanced Accelerator Applications International SA71
招募中
1 期
eoRay - Phase I/IIa trial of [177Lu]-NeoB in patients with advanced solid tumors and with [68Ga]-NeoB lesion uptake.CTIS2023-507170-41-00Advanced Accelerator Applications International S.A.51
进行中（未招募）
1 期
eoRay - Phase I/IIa trial of [177Lu]-NeoB in patients with advanced solid tumors and with [68Ga]-NeoB lesion uptake.EUCTR2018-004727-37-NLAdvanced Accelerator Applications International SA51