jRCT2051240092招募中不适用
[M24-742]A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
AbbVie.G.K.0 个研究点目标入组 12 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 主要终点
- Percentage of Participants With Adverse Events (AEs)
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（—）
入选标准
- •Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
- •Estimated life expectancy > 6 months.
- •Must have progressed on prior novel hormonal agents (NHAs) (e.g., abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or castration-resistant prostate cancer (CRPC). Determination of progression is done per local investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 and/or Prostate Cancer Working Group 3 (PCWG3).
- •Serum testosterone levels <= 50 ng/dL (<= 1.73 nmol/L) within the screening period and prior to the first dose of the study drug.
- •Must have received at least one NHA (e.g., enzalutamide and/or abiraterone). Additionally, participants must have received at least one taxane for prostate cancer (or have refused, or are intolerant to, or unable to get access to taxanes).
- •Must have >= 1 metastatic lesion that is present on baseline computed tomography (CT), magnetic resonance imaging (MRI), or bone scan imaging obtained <= 28 days prior to beginning study therapy.
- •Serum prostate specific antigen (PSA) level >= 1.0 ng/mL.
- •Availability of representative baseline tumor tissue (most recent archived tumor tissue after any novel hormonal agent (NHA) and/or any Prostate-Specific Membrane Antigen (PSMA) targeted therapy or fresh biopsy collected during screening phase) suitable for immunohistochemistry (IHC) testing. This requirement may be waived at the discretion of the AbbVie Medical Monitor if collecting a biopsy at screening would place the subject at risk of harm or would require a technically complicated procedure based on tumor location as assessed by the investigator.
- •Laboratory values meeting the criteria laid out in the protocol.
- •QT interval corrected for heart rate (QTc) < 470 msec (using Fridericia's correction), no >= Grade 3 arrythmia, and no other clinically significant cardiac abnormalities.
排除标准
- •Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
- •History of other active malignancy, as laid out in the protocol.
- •History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis on screening chest CT scan.
- •History of or active idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
- •History of or active clinically significant, intercurrent lung-specific illnesses including, but not limited to those listed in the protocol.
结局指标
主要结局
Percentage of Participants With Adverse Events (AEs)
时间窗: Up to 3 Years
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
Percentage of Participants Achieving Prostate Specific Antigen (PSA) response
时间窗: Up to 3 Years
PSA response is defined as >= 50% PSA decrease from baseline.
次要结局
- Maximum Observed Plasma Concentration (Cmax) of ABBV-969(Up to 3 Years)
- Time to Maximum Observed Concentration (Tmax) of ABBV-969(Up to 3 Years)
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-969(Up to 3 Years)
- Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969(Up to 3 Years)
- Antidrug Antibody (ADA)(Up to 3 Years)
- Neutralizing Antibodies (nAbs)(Up to 3 Years)
- Recommended Phase 2 Dose (RP2D) of ABBV-969 (Dose-Escalation Phase)(Up to 2 Years)
研究者
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