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진행성 췌장암 환자에서 IBI343과 항암화학요법 병용요법에 대한 임상 1상/2상 시험

IBI343 Combined With Chemotherapy in Advanced Pancreatic Cancer

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 NCT07692750
상태 모집 중
단계 1상/2상
시험 약물/중재 IBI343+ capecitabine, IBI343+Capecitabine+oxaliplatin
대상 질환 Advanced Pancreatic Cancer
스폰서 Zhejiang Cancer Hospital
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 56
시작 / 1차 완료 예정 2025-04-30 / 2027-06-30
국내 실시기관 없음
실시 국가 1개국, 기관 1곳 (China)
결과 게시 아니오
최근 갱신 2026-07-09

문의처 (등록된 중앙 연락처)

  • jieer ying +86 13858195803 hzyingjieer@163.com

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

시험 개요

본 임상시험은 CLDN18.2 양성 진행성 췌장암(PAC) 환자를 대상으로 IBI343과 항암화학요법(capecitabine 또는 capecitabine+oxaliplatin) 병용투여의 안전성, 내약성, 유효성을 평가합니다. 1상 안전성 도입 단계에서는 전통적인 3+3 용량증가 디자인을 통해 병용요법의 적정 용량을 결정합니다. 2상 코호트 확장 단계에서는 결정된 용량을 바탕으로 각각 약 32명(코호트 A)과 약 24명(코호트 B)의 환자에게 치료를 시행합니다. 환자는 질병 진행, 독성 불내성, 동의 철회 등의 사유가 발생할 때까지 치료를 지속합니다.

  • 목표 환자 수는 총 56명입니다.
  • 평가 대상은 이전 1차 젬시타빈(gemcitabine) 기반 전신 치료 후 진행 또는 불내성을 보인 CLDN18.2 양성 진행성 췌장암 환자입니다.
  • 중재 치료는 IBI343+capecitabine 병용(코호트 A) 또는 IBI343+capecitabine+oxaliplatin 병용(코호트 B)입니다.
  • oxaliplatin은 최대 8주기까지 투여하며, 이후 IBI343과 capecitabine 유지요법이 가능합니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 서면 동의서를 서명하고 프로그램 절차를 준수할 의향과 능력이 있는 자 - 조직학적으로 확인된 절제 불가능한 국소 진행성, 재발성 또는 전이성 췌장선암(PAC) - 국소 진행성 또는 재발성/전이성 단계에서 1차 젬시타빈(gemcitabine) 기반 전신 치료 후 진행 또는 불내성 - 근치적 치료(근치적 방사선화학요법 및/또는 수술)에 부적합한 자 - RECIST v1.1 기준에 따라 이전에 방사선 치료를 받지 않은 최소 1개의 측정 가능한 병변 보유 - 연령 18세 이상, 성별 무관 - 미국동부종양학협회 수행능상태(ECOG PS) 점수 0 또는 1 - 체질량지수(BMI) 17 kg/m2 이상 - 예상 생존기간 12주 이상 - 골수 및 장기 기능이 충분할 것 (절대호중구수(ANC) 1.5 x 10^9/L 이상, 혈소판 100 x 10^9/L 이상, 혈색소 9.0 g/dL 이상 등) - 가임 여성 및 가임 여성 파트너를 둔 남성 환자는 치료 기간 및 치료 종료 후 6개월 동안 효과적인 피임 조치 준수 - 조직병리학적 검사에서 CLDN18.2 양성 확인 (종양 세포의 40% 이상에서 면역조직화학 막 염색 강도 양성)

제외 기준: - 관찰(비중개) 연구 또는 중개 연구의 생존 추적 관찰 단계를 제외한 다른 중개 임상연구 참여 중인 자 - 연구 약물 최초 투여 전 2주 또는 반감기의 5배 중 긴 기간 내에 사이토크롬 P450 3A4(CYP3A4) 억제제 치료를 받은 자 - 연구 약물 첫 투여 4주 전 또는 항암 치료제 반감기의 5배 이내에 마지막 항암 치료를 받은 자 - 연구 약물 첫 투여 전 2주 이내에 치료적 또는 완화적 방사선 치료를 받은 자 - 연구 약물 첫 투여 전 7일 이내에 담도 스텐트 삽입술 또는 경피경간담도배액술(PTCD)을 시행한 자 - 연구 기간 동안 다른 항암 치료를 받을 계획인 자 - 연구 약물 첫 투여 전 4주 이내 또는 연구 기간 동안 생백신을 투여받은 자 - 연구 약물 첫 투여 전 4주 이내에 주요 수술을 받았거나 치유되지 않은 상처, 궤양, 골절이 있는 자 - 이전 치료로 인한 독성이 NCI CTCAE v5.0 기준 이하로 회복되지 않은 자 - 연구 약물 최초 투여 전 6개월 이내에 수술로 치유되지 않은 위장관 천공 및/또는 누공 병력 - 유문 폐쇄 및/또는 지속적이고 재발하는 구토가 있는 자 - 소화관 또는 기관지 내 스텐트 삽입술을 받은 자 - 증상이 있는 중추신경계 전이가 있는 자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  1. Sign a written Informed Consent Form (ICF) and be willing and able to comply with the visit and related procedures stipulated by the program.
  2. Histopathologically confirmed unresectable locally advanced, recurrent, or metastatic PAC.
  3. Progression or intolerance following first-line gemcitabine-based systemic therapy at locally advanced or recurrent/metastatic stages.If the time from the last neoadjuvant/adjuvant therapy to disease recurrence/metastasis is less than 6 months, the treatment is considered first-line therapy.
  4. The subject must not be suitable for radical treatment methods such as radical chemoradiotherapy and/or surgery.
  5. According to RECIST v1.1, at least 1 measurable lesion had not received prior radiotherapy.(At baseline, an intravenous contrast agent is preferred by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) to accurately measure nodes with a long diameter ≥10 mm except for the short axis of the lymph nodes≥15 mm Target lesion diameter ≥2 times image layer thickness and lesions suitable for repeated accurate measurement.If a lesion located in a previously irradiated area clearly demonstrates progression to RECIST V1.1 criteria, it can be considered a measurable lesion).
  6. Age ≥18 years old, gender is not limited.
  7. Score of 0 or 1 according to the Eastern Cooperative Oncology Group Performance Status (ECOG PS).
  8. BMI 17 kg/m2.
  9. Expected survival ≥12 weeks.

  10. With full bone marrow and organ function:

    A. routine blood ANC acuity 1.5 x 109 / L platelet count 100 x 109 or higher acuity 9.0 g/dL/L hemoglobin content subjects in blood sampling may not be received within 7 days before losing blood products (including red suspension, single mining platelet and cryoprecipitate, etc.), Erythropoietin,Granulocyte-colony Stimulating Factor or Granulocyte-Macrophage Colony-Stimulating Factor treatment b. Liver function TBIL≤1.5×ULN Subjects with Gilbert syndrome allowed TBIL≤3×ULN Subjects without liver metastasis ALT and AST≤2.5×ULN Subjects with liver metastasis ALT and AST≤5×ULN albumin ≥30 g/L c. Renal creatinine clearance ≥60 mL/min Urinary protein \< 2+ by Cockcroft-Gault formula or total urinary protein \< 1 g in 24h d. Coagulation function: International Normalized Ratio≤1.5 and Activated Partial Thromboplastin Time≤1.5×ULN (subjects who are allowed to receive anticoagulation therapy and whose coagulation function is in the above range).

  11. Female subjects of childbearing age or male subjects whose partners are women of childbearing age are required to take effective contraceptive measures throughout the treatment period and for 6 months after the treatment period.

  12. The histopathological test confirmed that *CLDN18.2 was positive.For subjects who have previously received any anti-CLDN18.2 treatment, tumor samples should be collected again after the relevant anti-CLDN18.2 treatment has ended.

Note:

*CLDN18.2 positive was defined as Claudin18.2 immunohistochemical membrane staining intensity ≥ acceptance of previous test results, center test results, and laboratory test results in ≥40% of tumor cells.The proportion of CLDN18.2 expression can be dynamically adjusted by sponsors and funders during the study based on newly generated data.

Exclusion Criteria:

  1. Participating in another interventional clinical study, other than an observational (non-interventional) clinical study or in the survival follow-up phase of an interventional study.
  2. Cytochrome P450 3A4 CYP3A4 (cytochrome P450 3A4) suppressant treatment within 2 weeks or 5 half-lives (whichever is longer) prior to the first administration of the study drug.
  3. Receive the last anti-tumor treatment 4 weeks before the first administration of the study drug or within 5 half-lives of the anti-tumor therapy drug (whichever is shorter) (drugs without an exact half-life need to be eluted for 2 weeks).
  4. Received therapeutic or palliative radiotherapy within 2 weeks prior to the first administration of the study drug.
  5. Biliary stenting or PTCD was performed within 7 days prior to the first use of the study drug.
  6. Plan to receive other anti-tumor therapy during the study drug treatment period [allowing palliative radiotherapy for the purpose of relieving symptoms (such as pain) without compromising the evaluation of efficacy].
  7. Receive any live vaccines within 4 weeks prior to the first administration of the study drug or during the study period.
  8. Had a major surgical procedure (craniotomy, thoracotomy, or laparotomy, or other procedure as defined by the investigator, excluding needle biopsy) or had an unhealed wound, ulcer, or fracture within 4 weeks prior to the first administration of the study drug;Or plan to require major surgery during the study.For the purpose of palliative care, local surgical treatment of isolated lesions is acceptable.
  9. Toxicity from prior treatment that did not return to NCI CTCAE v5.0 before first administration of the investigational drug (excluding alopecia, weakness, pigmentation, and other conditions deemed by the investigator to be of no safety risk).
  10. A history of gastrointestinal perforation and/or fistula within the 6 months prior to the first administration of the study drug that has not been cured by surgical treatment.
  11. Presence of pyloric obstruction and/or persistent recurrent vomiting (vomiting ≥ 3 times within 24 hours).
  12. Digestive tract [refers to the muscular duct from the mouth to the anal canal, including the mouth, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, ileum), large intestine (cecum, appendix, colon, rectum) and anal canal, etc.] or after endotracheal stent implantation.
  13. Symptomatic central nervous system metastasis.Participants with asymptomatic BMS (i.e., no neurological symptoms, no need for glucocorticoid therapy, all BMS ≤ 1.5 cm) or BMS with stable symptoms after treatment met all of the following criteria to be eligible for participation in this study: no midbrain, pontine, cerebellum, meninges, medulla bulbar, or spinal cord metastases;Clinical status remained stable for at least 4 weeks, clinical evidence confirmed no new or expanded brain metastases, and corticosteroids and anticonvulsants were discontinued for at least 2 weeks before first administration of the study drug.Note: The central nervous system is not a target lesion.
  14. Bone metastases at risk of paraplegia.
  15. Interstitial lung disease requiring steroid therapy, or a history of interstitial lung disease, non-infectious pneumonia, severely impaired lung function or uncontrolled lung disease, such as pulmonary fibrosis, severe radiation pneumonia, acute lung injury, etc., or suspected during screening.

  16. There are uncontrolled diseases such as:

    1. Investigate the presence of poorly controlled infections that require treatment with systemic anti-infective drugs (antibiotics, antivirals, or antifungals) in the week prior to the first administration of the drug.
    2. HIV-1/2 antibody positive in people with human immunodeficiency virus (HIV).
    3. Acute or chronic active Hepatitis B (defined as Hepatitis B surface Antigen HBsAg) and/or hepatitis B Core Antibody HBcAb positive with hepatitis B virusDNA copy number ≥ 104 copies /mL or ≥ 2000 IU/mL or acute or chronic active Hepatitis C [Hepatitis C Virus antibody (HCVAb) positive HCV RNA 103 copies /mL].Subjects below the above criteria after nucleotide antiviral therapy and those with HCV antibody positive but RNA negative tests were admitted.
    4. Active tuberculosis, receiving antituberculosis therapy or receiving antituberculosis therapy within 1 year prior to the first administration of the investigational drug.
    5. Active plum poisoning or latent syphilis requires treatment.
    6. Symptomatic congestive heart failure (NYHA Class II to IV), symptomatic or poorly controlled arrhythmia, QTc interval 480 ms, or a personal or family history of congenital long/short QT syndrome.
    7. Standardized treatment of poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg).
    8. There is a risk of gastrointestinal/respiratory fistula.
    9. pleural effusion, ascites, or pericardial effusion that is symptomatic and requires intervention (e.g. drainage).
    10. Esophageal or gastric varices that require immediate intervention (e.g., lapping or sclerotherapy) or that are considered to have a high risk of bleeding in the opinion of the investigator or in consultation with a gastroenterologist or hepatologist,Subjects with evidence of portal hypertension (including splenomegaly on imaging) or a history of varicose bleeding must undergo endoscopic evaluation within 3 months prior to the first administration of the study drug.
    11. Any life-threatening bleeding event or grade 3 or 4 gastrointestinal/varicose bleeding event requiring blood transfusion, endoscopic, or surgical treatment occurred in the 3 months prior to the first administration of the study drug.
    12. Study any arterial thromboembolic events, including myocardial infarction, unstable angina pectoris, cerebrovascular accident, and transient ischemic attack, within 6 months prior to the first administration of the drug.
    13. History of new or uncontrolled stable deep vein thrombosis, pulmonary embolism, or any other severe venous thromboembolism within the 3 months prior to the first administration of the investigational drug (implantable port of intravenous infusion or catheter-derived thrombosis or superficial venous thrombosis were not considered "severe" venous thromboembolism).
    14. hepatic encephalopathy, hepatorenal syndrome or Child-Pugh score > 7.
    15. Risk of intestinal obstruction or perforation (including, but not limited to, a history of acute diverticulitis, abdominal abscess) or a history of inflammatory bowel disease or extensive enterectomy (partial resection of the colon or extensive resection of the small intestine with chronic diarrhea), Crohn's disease, ulcerative colitis, etc.
    16. Other acute or chronic medical conditions or abnormalities in laboratory tests that may increase the risk associated with study participation or study drug administration, or interfere with the interpretation of study results, and, at the investigator's discretion, classify subjects as ineligible to participate in the study.
    17. Neurological, psychiatric, or social conditions that affect compliance with study requirements, significantly increase the risk of AE, or affect a subject's ability to provide a written ICF.

  17. History of other primary malignancies, except the following:

    Cured malignancies with no known active disease ≥ 2 years prior to study inclusion and a very low risk of recurrence;Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence;Carcinoma in situ with adequate treatment and no evidence of disease recurrence.

  18. Known history of immunodeficiency.

  19. History of allogeneic organ transplantation and hematopoietic stem cell transplantation.
  20. Previously received antibody drug conjugate therapy based on topoisomerase inhibitors.
  21. For subjects receiving drug therapy, there is a history of prior allergy to the corresponding drug or preparation.
  22. There are contraindications for subjects receiving medication.
  23. For subjects receiving medication, there is a history of drug-related adverse reactions leading to permanent discontinuation.
  24. Pregnant or lactating female subjects.
  25. Other investigators did not consider themselves eligible to participate in the study.

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

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