jRCT2031200362已完成不适用
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager Acapatamab in Subjects With Metastatic Castration-resistant Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen K.K.
- 入组人数
- 212
- 主要终点
- Number of participants with dose-limiting toxicity
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
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- Male
入选标准
- •Subject has provided informed consent prior to initiation of any study specific activities/procedures
- •Subjects with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting
- •Subjects must have undergone bilateral orchiectomy or must be on continuous ADT with a gonadotropin releasing hormone (GnRH) agonist or antagonist
- •Total serum testosterone </= 50 ng/dL or 1.7 nmol/L
- •Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
- •PSA level >/= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart
- •nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications
- •appearance of 2 or more new lesions in bone scan
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
- •Life expectancy >/= 6months
排除标准
- •Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue (agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for >/= 30 days prior to randomization are eligible
- •Prior PSMA-targeted therapy (subjects on prior therapy may be eligible if discussed with Amgen medical monitor prior to enrollment)
- •3, Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
- •Active autoimmune disease or any other diseases requiring immunosuppressive therapy while on study
- •Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose
- •Myocardial infarction, unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of acapatamab
- •Part 2 only:
- •Subjects on a prior PD-1 or PD-L1 inhibitor who experienced a Grade 3 or higher immune-related adverse event prior to first day of dosing
- •History or evidence of interstitial lung disease or active, non-infectious pneumonitis
- •Part 3 only:
- •Evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product
- •Part 6 only:
- •Subjects are excluded from this cohort if any of the following additional criteria apply:
- •Use of any known inhibitors or inducers of drug-metabolizing enzymes within 30 days prior to study start and through start of cycle
- •Use of the following components of the CYP phenotyping cocktail (midazolam HCl, warfarin sodium, vitamin K, omeprazole, and dextromethorphan HBr) within 14 days prior to cycle 1 day 1.
结局指标
主要结局
Number of participants with dose-limiting toxicity
时间窗: Up to 3 years
Parts 1, 2, 3, 4, 5, and 6 of the study
Number of participants with treatment-emergent adverse events
时间窗: Up to 3 years
Parts 1, 2, 3, 4, 5, and 6 of the study
Number of participants with treatment-related adverse events
时间窗: Up to 3 years
Parts 1, 2, 3, 4, 5, and 6 of the study
Number of participants with clinically significant changes in vital signs
时间窗: Up to 3 years
Parts 1, 2, 3, 4, 5, and 6 of the study
Number of participants with clinically significant changes in electrocardiogram (ECG)
时间窗: Up to 3 years
Parts 1, 2, 3, 4, 5, and 6 of the study
Number of participants with clinically significant changes in clinical laboratory tests
时间窗: Up to 3 years
Parts 1, 2, 3, 4, 5, and 6 of the study
次要结局
未报告次要终点
研究者
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