- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07803783
A Study to Compare the Efficacy and Safety of YL201 With Standard Chemotherapy in Patients With Metastatic Pancreatic Cancer After Failure of Gemcitabine-Based Systemic Chemotherapy
A Randomized, Controlled, Multicenter Phase III Study to Evaluate the Efficacy and Safety of YL201 Versus Liposomal Irinotecan in Combination With 5-Fluorouracil/Leucovorin in Participants With Metastatic Pancreatic Ductal Adenocarcinoma Who Have Failed Prior Gemcitabine-based Systemic Therapy
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: MediLink Study Team
- 전화번호: +86 512 62858368
- 이메일: clinicaltrials@medilinkthera.com
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200127
- Shanghai Jiaotong University School of Medicine
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연락하다:
- Study Coordinator
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants must voluntarily sign a written informed consent form (ICF) and be willing and able to comply with protocol requirements.
- Participants must be ≥18 and ≤75 years of age.
- Participants must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Participants must have a life expectancy of at least 3 months.
- Participants must have histologically or cytologically confirmed incurable metastatic pancreatic ductal adenocarcinoma (PDAC).
- Participants must have received and failed only one prior line of gemcitabine-based systemic therapy.
- Participants must have at least one measurable lesion according to RECIST v1.1.
- Participants must have adequate organ function as defined in the protocol.
- Participants must agree to follow the contraception requirements specified in the protocol.
Exclusion Criteria:
- Participants with another malignancy within 5 years before randomization.
- Participants with pathologically confirmed pancreatic cancer other than PDAC.
- Participants who have previously received B7-H3-targeted therapy.
- Participants who have previously received topoisomerase I inhibitor or antibody-drug conjugate containing topoisomerase I inhibitor.
- Participants who are concurrently enrolled in another clinical study, unless it is an observational, non-interventional study or the participant is in the follow-up period of an interventional study.
- Participants who have not met the protocol-specified washout requirements for prior systemic therapy, relevant concomitant medications, radiotherapy, or surgery before randomization, or who have not adequately recovered from prior surgery or are planning to undergo major surgery during the study.
- Participants with protocol-specified exclusionary conditions related to central nervous system (CNS) metastases, history of transplantation, immunosuppressive therapy, live vaccine administration, or autoimmune or inflammatory diseases.
- Participants with uncontrolled or clinically significant concomitant diseases, including serious gastrointestinal, cardiovascular or cerebrovascular, pulmonary, thromboembolic, bleeding-related, effusion-related, or ascites-related safety risks.
- Participants with recent serious infection, active infection, active tuberculosis or syphilis, HIV positivity or immunodeficiency, or active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Participants with unresolved toxicity from prior anticancer therapy that has not recovered to the level specified in the protocol.
- Participants with known hypersensitivity to any component of the study treatment, or a history of severe hypersensitivity reactions or severe infusion-related reactions.
- Participants who are pregnant or breastfeeding, planning to become pregnant or breastfeed, or who have any other medical, psychiatric, social, or compliance-related factors that, in the investigator's opinion, would make them unsuitable for participation in the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Tambotatug pelitecan
Tambotatug pelitecan, monotherapy
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Drug: Tambotatug pelitecan 2.0mg/kg (maximum 200mg) Intravenous infusion Every 3 weeks Treatment will continue until disease progression or unacceptable toxicity.
다른 이름들:
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활성 비교기: Chemotherapy
Active comparator: nal-IRI+5-FU/LV
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Liposomal irinotecan Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. 5 Fluorouracil Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. Leucovorin Intravenous infusion Every 2 weeks Treatment will continue until disease progression or unacceptable toxicity. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PFS by BICR
기간: Up to approximately 2 years
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Progression-free Survival (PFS) is assessed by Blinded Independent Central Review(BICR) per response evaluation criteria in solid tumors (RECIST) v1.1
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Up to approximately 2 years
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OS
기간: Up to approximately 2 years
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OS is defined as the time from randomization until death from any cause.
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Up to approximately 2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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PFS by investigator
기간: Up to approximately 2 year
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PFS per RECIST v1.1, as assessed by Investigator
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Up to approximately 2 year
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ORR
기간: Up to approximately 2 years
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Objective Response Rate (ORR), as assessed by BICR and Investigator
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Up to approximately 2 years
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DCR
기간: Up to approximately 2 years
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Disease Control Rate (DCR), as assessed by BICR and Investigator
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Up to approximately 2 years
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DoR
기간: Up to approximately 2 years
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Duration of Response (DoR), as assessed by BICR and Investigator
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Up to approximately 2 years
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TTR
기간: Up to approximately 2 years
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Time to Response (TTR), as assessed by BICR and Investigator
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Up to approximately 2 years
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Adverse Event
기간: Up to approximately 2 years
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The incidence and severity of AEs, SAEs and AESIs per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 6.0
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Up to approximately 2 years
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To evaluate the AUC
기간: Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the Cmax
기간: Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the Ctrough
기간: Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the CL
기간: Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the Vd
기간: Up to approximately 2 years
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Up to approximately 2 years
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To evaluate the t1/2
기간: Up to approximately 2 years
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Up to approximately 2 years
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Immunogenicity
기간: Up to approximately 2 years
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Incidence of anti-drug antibodies of YL201
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Up to approximately 2 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TAISHAN-305
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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