NCT03927573终止1 期
A Multicenter, Open-label, Dose-escalating, Phase I Trial With GEM3PSCA, a PSCA Targeted Bispecific Antibody Engaging T-cells, in Patients With Progressive Disease After Standard Systemic Therapy in Cancers With Positive PSCA Marker
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 23
- 试验地点
- 5
- 主要终点
- Incidence and intensity of adverse events
研究概览
简要总结
This dose-escalating phase I trial assesses for the first time the safety, the side effects and the harmlessness, as well as the therapeutical benefit of the new study drug GEM3PSCA in patients with prostate stem cell antigen (PSCA) expressing cancer types which failed to respond to standard therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, ≥ 18 years of age
- •Progressive PSCA positive cancer (urogenital tract (renal, transitional cell, prostate), non-small cell lung) refractory to standard treatments and with no other available standard or curative treatment
- •Measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Life expectancy of at least 2 months
- •Platelets > 50,000/µl
- •Hemoglobin > 9 g/dl
- •Adequate renal and hepatic laboratory assessments
- •Adequate pulmonary function with oxygen saturation (SpO2) ≥ 90 % and no structural pulmonary disease which might jeopardize patient safety according to judgement of the investigator
- •Left ventricular ejection fraction (LVEF) of ≥ 45 %
- •Existing port-system or central venous catheter resp. acceptance of implantation of a device
- •A female of childbearing potential may be enrolled providing she has a negative pregnancy test at screening visit and is routinely using a highly effective method of birth control resulting in a low failure rate (e.g. hormonal contraception, intrauterine device, total sexual abstinence or sterilization) until 3 months from the last study drug administration. Male patients must also practice a highly effective method of birth Control
- •Able to give written informed consent
排除标准
- •Other malignancy requiring active therapy
- •Non-measurable tumor disease
- •Patients with active brain metastases (patients with brain metastases or residue after resection with stable size for 6 months in MRI not older than 8 weeks, after consultation with the sponsor, are not excluded from the trial)
- •Use of chemotherapy and radiotherapy within 2 weeks prior to start of trial medication
- •Use of checkpoint inhibitors (having a marketing authorization) within a washout of 5 x t1/2 (half-life); patients with experimental checkpoint inhibitors at all
- •Other investigational drug within the past 4 weeks before start of trial medication
- •Patients undergoing renal dialysis
- •Pulmonary disease with clinical relevant hypoxia
- •Evidence of active, non-infectious pneumonitis or history of interstitial lung disease
- •Cardiac disease: i.e. heart failure NYHA (New York Heart Association) III or IV, unstable coronary artery disease
- •Active central nervous disease (e.g. Parkinson, multiple sclerosis, seizures) and stroke within last 6 months
- •Active gastrointestinal ulceration or bleeding within the last 6 months unless related to underlying malignant disease
- •Renal outflow obstruction, macroscopic or significant microscopic hematuria
- •Active infectious diseases considered by investigator to be incompatible with protocol
- •Major surgery within 28 days
- •Autoimmune diseases requiring steroids at a dose above 10 mg prednisolone equivalent or other immunosuppressants
- •Pregnant or breastfeeding women
- •Psychiatric disorders, drug and/or alcohol abuse
- •Known history of human immunodeficiency virus (HIV) or active/chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV)
- •Known hypersensitivity to GEM3PSCA excipients
- •Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lacking compliance)
- •Incapability of understanding purpose and possible consequences of the trial
- •Patients who should not be included according to the opinion of the investigator
研究组 & 干预措施
GEM3PSCA
Experimental
Application of GEM3PSCA, a PSCA targeted bispecific antibody engaging T-cells
干预措施: GEM3PSCA (Drug)
结局指标
主要结局
Incidence and intensity of adverse events
时间窗: End of Treatment (EOT) +14 days (DLT period)
graded according to CTCAE V4.03
Incidence of Dose limiting toxicity (DLT)
时间窗: End of Treatment (EOT) +14 days (DLT period)
Dose Limiting Toxicity is defined as any event at least possibly related to investigational medicinal product (IMP)
Maximum tolerated dose (MTD)
时间窗: End of Treatment (EOT) +14 days (DLT period)
MTD is the previous dose level of the cohort where a DLT is observed in at least wo subjects.
次要结局
- Prostate specific antigen (PSA) response in patients with prostate cancer(End of Treatment (EOT) +14 days (DLT period))
- Recommended phase 2 dose (RP2D)(From start of treatment until up to 14 days after last treatment cycle (2 initial cycles + max. 6 additional cycles per patient). Each cycle consists of 7 days treatment plus DLT evaluation period (14 days))
- Antitumor activity of GEM3PSCA according to RECIST1.1 (Response Evaluation Criteria in Solid Tumors)(End of Treatment (EOT) +14 days (DLT period))
- Overall survival (OS)(End of Treatment (EOT) + 14 days (DLT period))
- Influence on circulating tumor cells in patients with prostate cancer(Day 8 / End of Treatment (EOT))
研究者
研究点 (5)
Loading locations...
相似试验
终止
1 期
Dose-escalating Phase I Trial With GEM333 in Patients With Acute Myeloid LeukemiaAcute Myeloid LeukemiaRelapsed AMLRefractory AMLNCT03516760AvenCell Europe GmbH36
进行中（未招募）
1 期
Study Evaluating GZ17-6.02 in Patients With Advanced Solid Tumors or in Combination With Capecitabine in Metastatic Hormone Receptor Positive Breast CancerAdvanced CancerProstate Cancer MetastaticColo-rectal CancerSolid TumorSolid CarcinomaSolid Carcinoma of StomachCancer of StomachCutaneous T Cell LymphomaHead and Neck Squamous Cell CarcinomaCutaneous T-cell LymphomaCutaneous Squamous Cell CarcinomaBreast CancerLymphomaPancreatic CancerGastric CancerSarcomaBasal Cell CarcinomaNCT03775525Genzada Pharmaceuticals USA, Inc.127
终止
1 期
A Study of AMG 340 in Subjects With Metastatic Castrate-Resistant Prostate CarcinomaMetastatic Castration-resistant Prostate CancerNCT04740034Amgen42
进行中（未招募）
1 期
A Study of TNB-383B in Participants With Relapsed or Refractory Multiple MyelomaMultiple MyelomaNCT03933735AbbVie220
招募中
1 期
Safety and Preliminary Efficacy of MBS8(1V270) in Cancer Patients With Advanced Solid TumoursAdvanced Solid TumorCutaneous MelanomaNCT04855435MonTa Biosciences ApS106