An Early Phase 1 Trial to Assess Pharmacodynamic Effects of OMO-103 in Patients With Pancreatic Ductal Adenocarcinoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Measurable change in tumor biology
研究概览
简要总结
This early phase I trial studies the biological activity of OMO-103 in patients with pancreatic ductal adenocarcinoma that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). OMO-103 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial may help researchers determine how exposure to OMO-103 changes pancreatic tumor cells.
详细描述
PRIMARY OBJECTIVE:
I. To assess the pharmacodynamic effects of Myc inhibitor OMO-103 (OMO-103) in tumor biopsies from patients with pancreatic ductal adenocarcinoma (PDAC).
SECONDARY OBJECTIVE:
I. To assess safety and tolerability of the proposed therapy.
EXPLORATORY OBJECTIVE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must provide written informed consent before any study-specific procedures or interventions are performed
- •Must be ≥ 18 years old at the time of informed consent
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Clinically-confirmed diagnosis of locally-advanced or metastatic adenocarcinoma of the pancreas
- •Participants may be treatment naïve or have received prior therapy for the treatment of their PDAC. A minimum washout period of 14-days after completing the most recent line of therapy is required before a participant can initiate treatment with study agent(s)
- •Based on available imaging, participant must have at least one disease lesion that can be biopsied in accordance with institutional standards
- •Patient agrees to undergo a minimum of 2 biopsies (pre- and post-treatment). Note: at principal investigator (PI) discretion, archival sample may be obtained in lieu of pre-treatment biopsy
- •Hemoglobin ≥ 7.5 g/dL
- •Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L (> 1500 per mm^3)
- •Platelet count ≥ 75 x 10^9/L (> 100,000 per mm^3)
- •Calculated creatinine clearance > 50 mL/min/1.73m^2 (per Cockcroft-Gault equation)
- •Aspartate aminotransferase (AST)/alanine aminotransferase (ALT): ≤ 3 x upper limit of normal (ULN), or ≤ 5 x ULN in presence of liver metastases
- •Participants of childbearing potential (POCBP) must agree to abstain from sexual intercourse or use effective methods of contraception starting with the first dose of study therapy through 6 months from the last dose of study intervention
- •POCBP may participate provided they have a negative serum pregnancy test at screening and a negative serum OR urine pregnancy test within 7 days of starting treatment
- •Sperm-producing participants must agree to abstain from sexual intercourse or use effective contraception starting with the first dose through 6 months after last dose of study intervention
排除标准
- •Concomitant use of other anti-cancer therapy otherwise not permitted in this protocol, including: chemotherapy, immunotherapy, hormonal therapy (hormone replacement therapy is acceptable), radiotherapy (except for palliative), biological therapy, or other novel agent
- •Prior anti-cancer therapy within 2 weeks prior to study enrollment
- •Prior treatment with a MYC inhibitor
- •Known severe hypersensitivity to OMO-103 or to any excipient of these medicinal products, or history of allergic reactions attributed to compounds of similar chemical or biologic composition
- •Major surgery within 6 weeks prior to enrollment
- •Uncontrolled intercurrent illness including symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and myocardial infarction within 3 months of initiating study intervention
- •History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent
- •Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment
- •Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
研究组 & 干预措施
Treatment (OMO-103)
Patients receive OMO-103 IV over 30-45 minutes on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, tumor biopsies, and collection of blood samples throughout the study.
干预措施: Biopsy Procedure (Procedure)
Treatment (OMO-103)
Patients receive OMO-103 IV over 30-45 minutes on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, tumor biopsies, and collection of blood samples throughout the study.
干预措施: Biospecimen Collection (Procedure)
Treatment (OMO-103)
Patients receive OMO-103 IV over 30-45 minutes on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, tumor biopsies, and collection of blood samples throughout the study.
干预措施: Computed Tomography (Procedure)
Treatment (OMO-103)
Patients receive OMO-103 IV over 30-45 minutes on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, tumor biopsies, and collection of blood samples throughout the study.
干预措施: Magnetic Resonance Imaging (Procedure)
Treatment (OMO-103)
Patients receive OMO-103 IV over 30-45 minutes on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, tumor biopsies, and collection of blood samples throughout the study.
干预措施: Myc Inhibitor OMO-103 (Drug)
结局指标
主要结局
Measurable change in tumor biology
时间窗: Time of pretreatment biopsy (baseline) to completion of post-treatment biopsy
A change in tumor biology is defined as any difference in the cellular or molecular composition of the tumor or its surrounding environment that can be quantifiably measured between the pre- and post-treatment tissue samples. Will be reported as a binary outcome of observed change (e.g., yes/no) for each participant.
次要结局
- Incidence of treatment-related adverse events(Day 1 (i.e., start of study intervention) up to 30 days after last dose of study drug)
研究者
Charles D Lopez
Principal Investigator
OHSU Knight Cancer Institute