전이성 췌장관암(PDAC) 환자를 대상으로 한 ProAgio 병용 투여 제1/1b상 임상시험

ProAgio in Pancreatic Ductal Adenocarcinoma (PDAC)

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목	내용
등록번호	NCT06182072
상태	모집 중
단계	1상
시험 약물/중재	ProAgio Dose Levels (DL) 1,2,3,4, Gemcitabine, nab paclitaxel
대상 질환	Pancreatic Ductal Adenocarcinoma (PDAC)
스폰서	ProDa BioTech, LLC
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	46
시작 / 1차 완료 예정	2023-09-14 / 2027-06-30
국내 실시기관	없음
실시 국가	1개국, 기관 1곳 (United States)
결과 게시	아니오
최근 갱신	2025-10-01

문의처 (등록된 중앙 연락처)

• Damon R Michaels 615-614-1185 damon.michaels@medelis.com
• Zhi-Ren Lui zliu8@gsu.edu

국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내

시험 개요

이 임상시험은 이전에 치료받지 않은 전이성 췌장관암(PDAC) 환자를 대상으로 신약 ProAgio와 젬시타빈(gemcitabine), 닙-파클리탁셀(nab-paclitaxel, G-nP) 또는 아테톨리주맙(atezolizumab) 병용 요법의 안전성, 약동학 및 임상적 활성을 평가합니다. 연구는 용량 증량(dose-escalation) 단계와 확장(expansion) 단계로 나누어 진행됩니다. 목표 환자 수는 총 46명이며 국내 기관은 초록에 명시되지 않았습니다. 부작용, 약동학, 약력학 데이터를 수집하고 RECIST 기준에 따라 치료 반응을 평가합니다.

• 목표 환자 수는 46명이며 국내 참여 기관은 초록에 명시되지 않았습니다.
• ProAgio와 G-nP 또는 아테톨리주맙의 병용 투여에 대한 안전성과 권장 용량을 평가합니다.
• 이차 분석 계획에는 객관적 반응률(ORR), 반응 지속 기간, 무진행 생존기간(PFS), 전체 생존기간(OS)이 포함됩니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 만 18세 이상 - 조직학적 또는 세포학적으로 진단된 임상 4기 췌장관암(PDAC) - ECOG 수행 능력 평가 0-1 - 적절한 장기 기능 보유 (ANC ≥1.5 x 10^9/L, 혈소판 ≥100 x 10^9/L, 헤모글로빈 ≥9 g/dL 등) - RECIST 1.1 기준에 따른 측정 가능한 병변 존재

제외 기준: - 젬시타빈 및 닙-파클리탁셀 사전 노출 이력 - 임상적으로 유의미한 말초 신경병증 - 치료받지 않은 중추신경계(CNS) 병변 - 조절되지 않는 활동성 자가면역 질환 - 임신 중이거나 모유 수유 중인 여성

선정/제외 기준 원문 (영어)

Inclusion Criteria:

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:

6. Absolute Neutrophil Count ≥1.5 x 10'9/L

7. Platelets ≥100 x 10'9/L
8. Hemoglobin (Hgb) ≥9 g/dL
9. Serum creatinine \<1.5 mg/dL OR Creatinine Clearance ≥60 mL/min using Cockcroft-Gault formula
10. Total bilirubin ≤1.5 x ULN
11. Aspartate transaminase (AST) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if AST ≤5.0 x ULN
12. Alanine transaminase (ALT) ≤2.5 x ULN, except for subjects with liver metastasis, who may only be included if ALT ≤5.0 x ULN
13. Presence of measurable disease by RECIST 1.1 criteria
14. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
15. Written informed consent must be obtained prior to any screening procedures.
16. Normal ECG defined as the following: QTcF at screening \<450 ms (male subjects), \<460 ms (female subjects)

17. 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.

18. A woman of childbearing potential must have a negative serum (β-human chorionic gonadotropin [β-hCG]) or urine pregnancy test at screening.

19. 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.
20. 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.
21. 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.

Exclusion Criteria:

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:

1. 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

2. 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)

3. 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.

4. History of pneumonitis/interstitial lung disease

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

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