DRKS00031816招募中1 期
Phase I study to evaluate the safety, tolerability and preliminary efficacy of the bispecific PSMAxCD3 antibody CC-1 in men with biochemical recurrence of prostate cancer - ProSperA_CC-1
niversitätsklinikum Tübingen0 个研究点目标入组 38 人开始时间: 2023年5月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- Male
入选标准
- •Written informed consent
- •- Patient is able to understand and comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations
- •- Earlier histologic diagnosis of prostatic adenocarcinoma
- •- Low risk of rapid disease progression, defined as:
- •-PSA-DT > 1 year AND pathological ISUP grade < 4 for men with prior radical prostatectomy
- •-Interval to biochemical recurrence > 18 months AND biopsy ISUP grade < 4 for men with prior radiation therapy
- •-Biochemical recurrence (BCR) in compliance with the following 3 conditions:
- •-after having finished last definitive treatment
- •-PSA =0.2 ng/mL or PSA > nadir + 2 ng/mL (after definitive RT), with two increasing PSA values prior to study treatment
- •- no distant metastasis upon PSMA-PET imaging
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status = 1
- •-Male patients with partners of child-bearing potential, who are sexually active, must agree to the use of one highly effective form of contraception and one barrier method. This should be started from the signing of the informed consent and continue throughout period of taking study treatment and for 4 months after the last dose of study drug.
- •-Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 21 days prior to study treatment:
- •-Hemoglobin = 9 g/dl (Transfusion of packed red blood cells prior to enrolment allowed)
- •-Neutrophil count = 1,500/mm3
- •-Platelet count = 100,000/µl
- •-Bilirubin = 1.5 x upper limit of normal (ULN)
- •-ALT and AST = 2.5 x ULN
- •-?-GT = 2.5 x ULN
- •-PT-INR/PTT = 1.5 x ULN
- •-Creatine kinase = 2.5 x ULN
- •-Serum creatinine = 1.5 mg/dl or creatinine clearance = 60 ml/min
排除标准
- •-PSA >5 ng/ml.
- •-For men with prior radical prostatectomy:
- •-PSA-DT < 1 year
- •- pathological ISUP grade 4-5
- •-For men with prior radiation therapy:
- •- Interval to biochemical recurrence < 18 months
- •- biopsy ISUP grade 4-5
- •- Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and low-grade non-muscle invasive papillary bladder cancer.
- •- Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy
- •- Patients who are receiving androgen-deprivation therapy.
- •- Patients who have received prior ADT are not eligible with the exception of those that received ADT = 36 months in duration and =9 months before enrolment and administered only in the neoadjuvant/adjuvant setting.
- •- Castrate level of serum testosterone <50 ng/dL at screening.
- •- History of HIV infection
- •- Viral active or chronic hepatitis (HBV or HCV)
- •- Ongoing autoimmune disease
- •- Current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
- •-Therapeutic anticoagulation
- •- Non-controlled hypertension, defined as mean blood pressure values in 24-hours blood pressure measurement of >130 mmHg or >90 mmHg for systolic or diastolic, respectively
- •- Heart failure defined as NYHA III/IV
- •- Severe obstructive or restrictive ventilation disorder
- •- Known intolerance to CC-1 or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in CC-1
研究者
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