A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 152
- 试验地点
- 47
- 主要终点
- Percentage of Participants Achieving Prostate Specific Antigen (PSA) response
研究概览
简要总结
Prostate cancer has the second highest incidence rate and is the fifth leading cause of cancer-related deaths among men worldwide. The purpose of this study is to assess safety, pharmacokinetics, and efficacy of ABBV-969 as a monotherapy.
ABBV-969 is an investigational drug being developed for the treatment of metastatic castration-resistant prostate cancer (mCRPC). There are parts to this study. Participants will receive ABBV-969 as a single agent at different doses. Approximately 230 adult participants will be enrolled in the study across sites worldwide.
In part 1 (dose escalation), ABBV-969 will be intravenously infused in escalating doses as a monotherapy. In part 2, multiple doses will be selected from Part 1 and mCRPC participants will be assigned to one of these doses in a randomized fashion to determine the recommended Phase 2 dose. The estimated duration of the study is up to 3 years.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65+ years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate.
- •Estimated life expectancy > 6 months.
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •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 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 if collecting a fresh biopsy at screening is deemed safe in the judgment of the investigator) suitable for immunohistochemistry (IHC) testing.
- •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.
研究组 & 干预措施
Part 2 A: Monotherapy Dose Expansion/Dose Optimization
Participants with mCRPC will receive dose A of ABBV-969 (dose levels determined in Part 1) for dose optimization.
干预措施: ABBV-969 (Drug)
Part 2 B: Monotherapy Dose Expansion/Dose Optimization
Participants with mCRPC will receive Dose B of ABBV-969 (dose levels determined in Part 1) for dose optimization.
干预措施: ABBV-969 (Drug)
Part 1: ABBV-969 Monotherapy Dose Escalation
Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive ABBV-969 monotherapy once every 21 days
干预措施: ABBV-969 (Drug)
结局指标
主要结局
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.
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.
次要结局
- Antidrug Antibody (ADA)(Up to 3 Years)
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-969(Up to 3 Years)
- Maximum Observed Plasma Concentration (Cmax) of ABBV-969(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)
- Time to Maximum Observed Concentration (Tmax) of ABBV-969(Up to 3 Years)
- Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-969(Up to 3 Years)
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG