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临床试验 NCT06182072 针对胰腺导管腺癌 (PDAC)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情,或在此提出任何问题。
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ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC) I期 46 开放性试验

招募中
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临床试验NCT06182072旨在研究治疗,主要针对胰腺导管腺癌 (PDAC)。这是一项I期 干预性研究试验,目前试验状态为招募中。试验始于2023年9月14日,计划招募46名患者。该研究由ProDa BioTech, LLC主导,预计于2028年6月30日完成。试验数据来源于ClinicalTrials.gov,最后更新时间为2025年10月1日
简要概括
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine, nab-paclitaxel (G-nP) or gemcitabine, nab-paclitaxel (G-nP) and atezolizumab in previously untreated subjects with metastatic pancreatic ductal adenocarcinoma (PDAC)
详细描述
This is an open-label Phase I/Ib dose-escalation, dose-expansion clinical trial of the safety, pharmacokinetics and clinical activity of ProAgio combined with gemcitabine, nab-paclitaxel (G-nP) or gemcitabine, nab-paclitaxel (G-nP) and atezolizumab in previously untreated subjects with metastatic PDAC. The study will use an EWOC design in Phase I to determine the recommended RP2D of ProAgio with gemcitabine, nab pacl...显示更多
官方标题

A Phase I/Ib Trial of ProAgio, an Anti- αvβ3 Integrin Cytotoxin, in Combination With Gemcitabine and Nab-paclitaxel or Gemcitabine, Nab-paclitaxel and Atezolizumab for Advanced Pancreatic Cancer

疾病
胰腺导管腺癌 (PDAC)
出版物
关于此临床试验发表的科学文章和研究论文:
其他研究标识符
  • UAB 2335 v2.1
NCT编号
实际开始日期
2023-09-14
最近更新发布
2025-10-01
预计完成日期
2028-06-30
计划入组人数
46
研究类型
干预性研究
试验分期 (阶段)
I期
试验状态
招募中
主要目的
治疗方法
分配方式
非随机
干预模型
序贯设计
盲法
无(开放性试验)
试验组/干预措施
参与者组/试验组干预措施/治疗方法
实验性Dose Escalation
ProAgio Dose Levels (DL) 1,2,3,4 ProAgio combined with gemcitabine, and nab paclitaxel is administered to study participants by intravenous injections on days 1, 8, 15, 21 every 4-week Cycle, gemcitabine and nab paclitaxel on day 1, 8, 15 every 4-week cycle during the study. Other Names: ACT50, G-nP: Gemcitabine, nab-Paclitaxel
ProAgio Dose Levels (DL) 1,2,3,4
ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.
Gemcitabine, nab paclitaxel
ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.
实验性Standard Arm
In cycle 1 of dose expansion phase of the study, half of patients (n=6) will be administered ProAgio only on day 1, 8, 15, 22 every 4-week Cycle, and half of patients (n=6) will be administered gemcitabine and nab paclitaxel are administered day 1, 8, 15 every 4-week cycle. In the atezolizumab containing cohort atezolizumab will be administered day 1 of cycle 1, and then will be repeated every 3 weeks. Other Names: ...显示更多
ProAgio Dose Levels (DL) 1,2,3,4
ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.
Gemcitabine, nab paclitaxel
ProAgio combined with gemcitabine and nab paclitaxel (G-nP) in previously untreated subjects with metastatic PDAC.
主要终点
结果指标度量标准描述时间框架
Determine the safety of ProAgio combined with gemcitabine and nab paclitaxel.
Physical examination, vital signs, clinical laboratory evaluations (CBC, serum chemistry, coagulation studies, LFTs, and assessment of subject reported AEs (via CTCAE v5.0) and SAEs will be used to evaluate safety.
2 Years
Determine the patient's height.
Height measured in Centimeters (cm)
2 Years
Determine the patient's weight.
Weight measured in Kilograms (kg)
2 Years
Determine the patient's body temperature.
Body Temperature measured in Celsius
2 Years
Determine the patient's Respiration Rate.
Respiration Rate measured in times/min
2 Years
Determine the patient's Heart Rate.
Heart Rate measured in beats/min
2 Years
Determine the patient's Systolic Blood Pressure
Systolic Blood Pressure measured in mmHg
2 Years
Determine the patient's Diastolic Blood Pressure.
Diastolic Blood Pressure measured in mmHg
2 Years
Determine the patient's Pulse Oximetry.
Perform Pulse Oximetry measured in (SpO2)
2 Years
Determine a single ideal dose which will be selected for further investigation in the dose escalation cohort.
Following completion of the dose escalation cohort, all available data relating to the pharmacokinetics, pharmacodynamics, efficacy and safety of ProAgio combined with gemcitabine and nab paclitaxel will be reviewed by the study team including the Principle Investigator, clinical pharmacology collaborators and the sponsor. A single ideal dose will then be selected for further investigation in the dose escalation cohort. This ideal dose may or may not be the same as the MTD.
2 Years
次要终点
结果指标度量标准描述时间框架
Determine the total integrated area under the plasma drug concentration-time curve (AUC).
Analyze pharmacokinetics to determine the total integrated area under the plasma drug concentration-time curve (AUC).
2 Years
Determine the Peak Plasma Concentration (Cmax).
Pharmacokinetics will be analyzed by determining Peak Plasma Concentration (Cmax).
2 Years
Determine how well the patient eliminates the study drug (CL).
Pharmacokinetics will be analyzed by determining how well the patient eliminates the drug (CL).
2 Years
Determine Volume of distribution (Vd).
Pharmacokinetics will be analyzed by determining Volume of distribution (Vd).
2 Years
Determine the study drug half-life (t1/2).
Pharmacokinetics will be analyzed by determining the study drug half-life (t1/2).
2 Years
An attempt will be made to determine dose proportionality of ProAgio.
Pharmacokinetics will be analyzed by determining the amount of drug reaching the systemic circulation.
2 Years
Evaluate Objective response rate (ORR).
Objective response rate (ORR), defined as complete response (CR) or partial response (PR) through cycle 6 per RECIST 1.1 as a proportion of n=6 of the Phase1b cohorts.
2 Years
Evaluate Duration of response (DOR).
Duration of response (DOR), determined from date of best response to progression or death.
2 Years
Evaluate Progression-free Survival (PFS).
Progression-free Survival (PFS), determined from date of 1st dose of study drug to progression or death.
2 Years
Evaluate Overall Survival (OS).
Overall Survival (OS) determined from date of 1st dose of study drug to death from any cause. CA19-9 will be assessed by descriptive statistics.
2 Years
Evaluate patient tumor response.
MR imaging assessment of patient tumor response using a unique MRI photon to monitor tumor changes and tumor blood perfusion changes.
2 Years
参与助手
资格标准

适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
  1. Must be ≥ 18 years of age on day of signing informed consent.

  2. Histologic or cytologic diagnosis of pancreatic adenocarcinoma with clinical stage IV.

  3. In the dose escalation phase: patients must be eligible for gemcitabine and nab paclitaxel. For dose expansion phase: patients must have received 5FU-based therapy for metastatic disease or for neoadjuvant/adjuvant therapy in prior 12 months.

  4. Presence of a lesion that can be safely biopsied for correlative assays.

  5. Patient must meet the following laboratory values at the screening visit:

    • Absolute Neutrophil Count ≥1.5 x 10'9/L
    • Platelets ≥100 x 10'9/L
    • Hemoglobin (Hgb) ≥9 g/dL
    • Serum creatinine <1.5 mg/dL OR Creatinine Clearance ≥60 mL/min using Cockcroft-Gault formula
    • Total bilirubin ≤1.5 x ULN
    • Aspartate transaminase (AST) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if AST ≤5.0 x ULN
    • Alanine transaminase (ALT) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if ALT ≤5.0 x ULN
  6. Presence of measurable disease by RECIST 1.1 criteria

  7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

  8. Written informed consent must be obtained prior to any screening procedures.

  9. Normal ECG defined as the following: QTcF at screening <450 ms (male subjects), <460 ms (female subjects)

  10. Before enrollment, a woman must be either:

    1. Not of childbearing potential: postmenopausal (>45 years of age with amenorrhea for at least 12 months or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level >40 IU/mL); permanently sterilized (eg, tubal occlusion, hysterectomy, bilateral salpingectomy); or otherwise be incapable of pregnancy.
    2. Of childbearing potential and practicing (during the study and for 6 months after receiving the last dose of study agent) a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies: eg, established use of oral, injected or implanted hormonal methods of contraception; placement of an intrauterine device (IUD) or intrauterine system (IUS); barrier methods; true abstinence (when this is in line with the preferred and usual lifestyle of the subject).
    3. Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active) a woman must begin a highly effective method of birth control, as described above.
  11. A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin \[β-hCG\]) or urine pregnancy test at screening.

  12. During the study and for 6 months after receiving the last dose of study agent, a woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction.

  13. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control eg, either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository, and all men must also not donate sperm during the study and for 3 months after receiving the last dose of study drug.

  14. Sign an informed consent document indicating that they understand the purpose of and procedures required for the study, are willing to participate in the study, and are willing and able to adhere to the prohibitions and restrictions specified in this protocol. Informed consent must be obtained before performing any study specific procedures.

  1. Prior exposure to gemcitabine and nab paclitaxel

  2. Clinically significant peripheral neuropathy

  3. Any untreated central nervous system (CNS) lesion. However, subjects are eligible if:

    a) all known CNS lesions have been treated with radiotherapy or surgery and b) patient remained without evidence of CNS disease progression ≥4 weeks after treatment.

  4. Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GMCSF, M-CSF), thrombopoietin mimetics or erythroid stimulating agents ≤ 2 weeks prior start of study treatment. If erythroid stimulating agents were initiated more than 2 weeks prior to the first dose of study treatment and the patient is on a stable dose, they can be maintained.

  5. Active unstable autoimmune disease. Documented history of autoimmune disease that is well controlled on stable immune suppressive therapy can be enrolled after discussion with principal investigator.

  6. Allogenic bone marrow or solid organ transplant.

  7. Known history or current interstitial lung disease or non-infectious pneumonitis.

  8. Malignant disease, other than that being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.

  9. Clinically significant infection, including known HIV or hepatitis C infection, or known hepatitis B surface antigen positivity. Testing of asymptomatic patients will not be required.

  10. Clinically significant ongoing infection.

  11. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 14 days or 5 half-lives before enrollment or is currently enrolled in the treatment stage of an investigational study.

  12. A woman who is pregnant or breast-feeding, or a woman who is planning to become pregnant or a man who plans to father a child while enrolled in this study or within 30 days after the last dose of study agent.

  13. Had hospitalization for infection or major surgery (eg, requiring general anesthesia) within 2 weeks before enrollment or have not fully recovered from surgery. Note: subjects with surgical procedures conducted under local anesthesia may participate.

  14. History or current diagnosis of cardiac disease indicating significant risk of safety for subjects participating in the study such as uncontrolled or significant cardiac disease, including any of the following:

    1. recent myocardial infarction (within last 6 months),
    2. uncontrolled congestive heart failure,
    3. unstable angina (within last 6 months),
    4. clinically significant (symptomatic) cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker).

    Following additional exclusion criteria applies only to the patients in the cohort including atezolizumab:

  15. Active or prior documented autoimmune or inflammatory disorders (including, but not limited to inflammatory bowel disease \[e.g., colitis or Crohn's disease\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:

    • Patients with vitiligo or alopecia
    • Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
    • Any chronic skin condition that does not require systemic therapy
    • Patients without active disease in the last 5 years may be included but only after consultation with the study physician
    • Patients with celiac disease controlled by diet alone
    • Patients with type I diabetes mellitus who are on an insulin regimen are eligible for the study
  16. Current or prior use of immunosuppressive medication ≤ 14 days prior to registration.

    The following are exceptions to this criterion:

    • Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection)
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
  17. Receipt of live attenuated vaccine ≤30 days prior to registration. Note: Patients, if enrolled, should not receive live vaccine whilst on study treatment and up to 30 days after the last dose of study treatment.

  18. History of pneumonitis/interstitial lung disease

ProDa BioTech, LLC logoProDa BioTech, LLC
研究中心联系人
联系人: Damon R Michaels, 615-614-1185, [email protected]
联系人: Zhi-Ren Lui, [email protected]
1 位于 1 个国家/地区的研究中心

Alabama

O'Neal Comprehensive Cancer Center, University of Alabama, Birmingham, Alabama, 35294, United States
Mehmet Akce, MD, 联系人, [email protected]
招募中