A Phase 1a/1b Open Label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of JUR-003 in Adult Patients With Metastatic Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 210
- 试验地点
- 3
- 主要终点
- Safety and Tolerability
研究概览
简要总结
JUR-003-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumor activity of JUR-003 in patients with prostate cancer. This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled.
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 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Must be ≥18 years of age at the time the informed consent form (ICF) is signed.
- •Has a histologically or cytologically confirmed adenocarcinoma of the prostate.
- •Has either of the following:
- •Measurable disease per RECIST v1.1 (with PCWG3 modifications)
- •Evaluable disease per PCWG4, as assessed by the local site Investigator/radiology
- •For Part 2.1B (omPC expansion) only: PSMA-avid disease on PSMA-PET, defined as lesion(s) demonstrating uptake above blood pool (PSMA score ≥1) and assessed by the Investigator as consistent with metastatic prostate cancer, in the setting of biochemical recurrence (PSA ≥0.2 ng/mL).
排除标准
- •Has a diagnosis of immunodeficiency.
- •Has had a prior stem cell, bone marrow, or organ transplant.
- •Has a known history of human immunodeficiency virus (HIV) infection.
- •Has active or chronic hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
- •Has an active autoimmune disease (non-immunotherapy induced conditions) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
- •Has a history of (noninfectious) pneumonitis that required steroids or current active organizing pneumonitis/interstitial lung disease.
- •Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Individuals with previously treated CNS metastases may participate in JUR-003 monotherapy cohorts (Parts 1.1, 2.1, and 1.3 where applicable) provided they are radiologically stable (ie, without evidence of progression for at least 2 weeks by repeat imaging [note that the repeat imaging should be performed during study Screening]), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study drug.
- •Has untreated spinal cord compression. Individuals must be neurologically stable off steroids for at least 4 weeks prior to first dose of study drug.
- •Has a history of a previous secondary malignancy within 3 years of Screening (except basal cell or squamous cell carcinoma of the skin or carcinoma in situ treated with curative therapy or other localized, low-grade tumors deemed cured, or whose natural history does not have the potential to interfere with the safety or efficacy assessments of the current study and not treated with systemic anticancer therapy [except hormonal therapy]).
- •Has a known psychiatric or substance abuse disorder that would interfere with the individuals' ability to cooperate with the requirements of the study.
- •Has a history of venous thromboembolic events (eg, pulmonary embolism) within 1 month prior to the first dose of JUR-
- •Uncomplicated (Grade ≤2) deep vein thrombosis is not considered exclusionary.
研究组 & 干预措施
Part 1 (Dose Escalation)
Participants will receive JUR-003 to determine the recommended dose for expansion (RDE) regimen.
干预措施: JUR-003 (Biological)
Part 2 (Dose Expansion)
Participants will receive JUR-003 at the RDE as determined in Part 1 of the study to confirm the safety and anti-tumor activity.
干预措施: JUR-003 (Biological)
结局指标
主要结局
Safety and Tolerability
时间窗: 2 years
The safety and tolerability of JUR-003 in patients with prostate cancer measured by frequency and severity of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), adverse events of special interest (AESIs), adverse events (AEs) leading to dose interruption and of adverse events (AEs) leading to treatment discontinuation
Determine Recommended Dose for Expansion
时间窗: 1 year
To determine the maximum tolerated dose (MTD) and/or select the recommended dose(s) for expansion (RDE\[s\]) of JUR-003
Characterize Pharmacokinetics
时间窗: 2 years
To characterize the pharmacokinetics (PK) of JUR-003 with Cmax following administration
次要结局
未报告次要终点