A Phase 1b/2a, Double-blind, Placebo-controlled, Three Arm, Randomized Study Evaluating a Single Intravenous Push Followed by a Continuous Infusion of Certepetide Over 4 Hours When Added to Standard of Care (SoC) Versus Two Intravenous Pushes of Certepetide When Added to SoC, Versus SoC Alone in Subjects With Previously Untreated Metastatic Pancreatic Ductal Adenocarcinoma (FORTIFIDE)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 30
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The goal of this clinical trial is to test a new drug plus standard treatment compared with standard treatment alone in people with metastatic pancreatic ductal adenocarcinoma.
The main questions it aims to answer are:
- is the new drug plus standard treatment safe and tolerable
- is the new drug plus standard treatment more effective than standard treatment
Participants will:
- Visit the clinic three times every 28 days for treatment and tests
- Have CT or MRI scans every 8 weeks while on treatment
详细描述
This is a Phase 1b/2a, double-blind, placebo-controlled, three-arm, randomized study evaluating a single intravenous push of certepetide followed by a continuous infusion of certepetide over 4 hours when added to standard of care (SoC) versus two intravenous pushes of certepetide given 4 hours apart when added to SoC, versus SoC alone in people with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC).
The study will consist of a screening period, a run-in period, a treatment period, an end-of-treatment follow-up visit, and a long-term follow up period.
Participants who provide informed consent will be screened for eligibility within 28 days prior to beginning the study treatment run-in period. Once eligibility is confirmed, participants will be randomized to one of the three treatment groups.
During the 3-day run-in period, participants will only receive the LSTA1 or placebo components of their randomized treatment regimen. After the 3-day run-in, Cycle 1 of treatment will commence. Tumor scans will be performed every 8 weeks (56 days ± 7 days) while on treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma that has not been treated previously and be eligible for treatment with nab-paclitaxel and gemcitabine
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- •Life expectancy ≥ 3 months
- •At least one measurable tumor lesion as assessed by RECIST 1.1
- •Adequate organ and marrow function
- •Adequate contraception
排除标准
- •Concurrent use of any other anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy, or biological agents
- •Received prior anti-cancer therapy for their pancreatic cancer
- •Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of subject safety or study results, including but not limited to:
- •Any major surgery or irradiation less than 4 weeks prior to baseline disease assessment
- •Active infection (viral, fungal, or bacterial) requiring systemic therapy
- •Known active hepatitis B virus, hepatitis C virus, or HIV infection
- •Active tuberculosis as defined per local guidance
- •History of allogeneic tissue/solid organ transplant
- •Prior malignancy requiring active treatment within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast
- •Pregnant or breastfeeding
- •Clinically significant or symptomatic cardiovascular/cerebrovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before randomization
- •History or clinical evidence of symptomatic central nervous system (CNS) metastases
- •Enrolled in any other clinical protocol or investigational trial
研究组 & 干预措施
SoC chemotherapy plus two certepetide IV pushes and placebo infusion
干预措施: nab-paclitaxel (Drug)
SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion
干预措施: placebo matching certepetide (Drug)
SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion
干预措施: certepetide (Drug)
SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion
干预措施: nab-paclitaxel (Drug)
SoC chemotherapy plus one certepetide IV push, one placebo IV push, and certepetide infusion
干预措施: gemcitabine (Drug)
SoC chemotherapy plus two certepetide IV pushes and placebo infusion
干预措施: gemcitabine (Drug)
SoC chemotherapy plus two certepetide IV pushes and placebo infusion
干预措施: certepetide (Drug)
SoC chemotherapy plus two certepetide IV pushes and placebo infusion
干预措施: placebo matching certepetide (Drug)
SoC chemotherapy plus two placebo IV pushes and placebo infusion
干预措施: nab-paclitaxel (Drug)
SoC chemotherapy plus two placebo IV pushes and placebo infusion
干预措施: gemcitabine (Drug)
SoC chemotherapy plus two placebo IV pushes and placebo infusion
干预措施: placebo matching certepetide (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: 30 days after treatment discontinuation
The National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE) will be used to grade the intensity of adverse events throughout the study
次要结局
未报告次要终点