진행성 췌장암 2차 치료를 위한 becotatugvedotin과 젬시타빈 병용 요법 임상시험¶
MRG003 With Gemcitabine for Second-line Advanced 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 | NCT07685470 |
| 상태 | 모집 예정 |
| 단계 | 1상/2상 |
| 시험 약물/중재 | becotatugvedotin plus gemcitabine |
| 대상 질환 | Pancreatic Ductal Adenocarcinoma (PDAC), Second Line Treatment |
| 스폰서 | Peking Union Medical College Hospital |
| 연령·성별 | 18 Years ~ 75 Years · ALL |
| 목표 인원 | 30 |
| 시작 / 1차 완료 예정 | 2026-06-08 / 2028-05-07 |
| 국내 실시기관 | 없음 |
| 실시 국가 | 0개국, 기관 0곳 |
| 결과 게시 | 아니오 |
| 최근 갱신 | 2026-07-06 |
문의처 (등록된 중앙 연락처)¶
- XIANG WANG 861069158751 wangxiang@pumch.cn
국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내
시험 개요¶
이 연구는 진행성 췌장암(PDAC) 2차 치료 환자를 대상으로 becotatugvedotin과 gemcitabine(젬시타빈) 병용 요법의 내약성, 권장 용량, 유효성 및 안전성을 평가하는 1상 및 2상 임상시험입니다. 총 27~30명의 국소 진행성 절제 불가능 또는 전이성 췌장암 환자를 목표로 합니다. 1상에서는 용량 제한 독성(DLTs)을 평가하고 2상 권장 용량을 결정하며, 2상은 결정된 용량으로 유효성을 평가합니다.
- 목표 환자 수는 총 27명에서 30명입니다.
- 1상에서는 becotatugvedotin 1.5 mg/kg 또는 2.0 mg/kg을 3주 주기로 3+3 용량증가 방식으로 평가합니다.
- gemcitabine은 각 3주 주기의 1일 차와 8일 차에 1000 mg/m² 용량으로 투여됩니다.
- 참여 대상은 18세부터 75세 사이의 2차 치료가 필요한 진행성 췌장암 환자입니다.
참여 조건 (AI 정리, 원문 확인 필요)¶
선정 기준: - ECOG 수행 능력 점수 0~2 - 조직학적으로 확인된 국소 진행성 절제 불가능 또는 전이성 췌장 방광 선암종(PDAC) - 이전 1차 전신 치료 실패(방사선학적 진행 또는 1차 치료 불내성) - 적절한 장기 및 골수 기능 - 예상 여명 3개월 초과 - EGFR 및 PD-L1 면역조직화학 검사, 차세대 염기서열 분석(NGS)을 위한 종양 조직 샘플 제공 동의
제외 기준: - 이전 1차 젬시타빈 기반 치료 실패 - 신경내분비종양, 선방세포암종 등 다른 조직학적 형태의 췌장 종양 - 이전 MMAE 탑재 항체-약물 접합체(ADC) 치료 경험 - 선천성 또는 후천성 면역결핍, 활동성 B형 또는 C형 간염 - 연구 약물에 대한 알려진 과민반응 - 무작위 배정 전 6개월 이내 심근경색, 불안정성 협심증, 심부전 발생 - 임신 또는 수유 중인 여성
선정/제외 기준 원문 (영어)
Inclusion Criteria:
ECOG performance status score of 0-2;
Histopathologically confirmed locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC);
Failure of prior first-line systemic therapy:
- Radiographic progression or worsening of clinical symptoms; disease progression occurring within 6 months after completion of neoadjuvant/adjuvant therapy is also considered first-line treatment failure.
- Intolerance to first-line therapy, as fully assessed by the investigator, may also allow enrollment into the study. Intolerance to prior study treatment is defined as follows:
i. Any grade ≥3 hematologic toxicity (per NCI-CTCAE v5.0) that does not recover to grade 1 or pre-treatment level after 14 days of best supportive care; ii. Any grade ≥3 non-hematologic toxicity (excluding alopecia and asymptomatic laboratory abnormalities) per NCI-CTCAE v5.0 that does not recover to normal after 14 days of best supportive care.
Adequate organ and bone marrow function;
Estimated life expectancy > 3 months;
Subjects must agree to provide sufficient tumor tissue samples for EGFR and PD-L1 immunohistochemistry (IHC) expression testing, next-generation sequencing (NGS), and multi-omics analysis. This includes archived tumor samples (paraffin blocks or unstained sections meeting the testing requirements specified in the study); if no archived tumor tissue sample is available, the subject agrees to undergo re-biopsy of the tumor lesion.
Exclusion Criteria:
- Failure of first-line gemcitabine-based therapy.
Other histologic types of pancreatic tumors, such as neuroendocrine tumors, acinar cell carcinoma, cystic carcinoma, etc.
Prior treatment with an MMAE-loaded ADC (antibody-drug conjugate).
Congenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).
Known hypersensitivity to the study drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies.
Occurrence of the following within 6 months before randomization: myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) Class ≥2 cardiac insufficiency, or symptomatic congestive heart failure.
Vaccination with a live vaccine within 4 weeks before the first dose of study drug. Inactivated virus vaccines for seasonal influenza (administered by injection) are permitted, but live attenuated influenza vaccine administered via the intranasal route is not allowed.
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Known history of substance abuse (psychoactive drugs) or drug addiction.
Pregnant or breastfeeding women.
Diagnosis of any other malignancy within 5 years before study entry, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma that have been treated with local therapy and cured.
Presence of any other serious physical or psychiatric illness, or laboratory abnormalities that may increase the risk of study participation, interfere with the study results, or render the patient unsuitable for participation in the opinion of the investigator.
Note: Subjects with hepatitis B meeting the following criteria may also be enrolled:
HBV viral load \< 1000 copies/mL (\<200 IU/mL) before the first dose, and the subject must receive anti-HBV therapy during the entire study treatment period to prevent viral reactivation.
For subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.
Subjects with active HCV infection (positive HCV antibody and HCV-RNA levels above the lower limit of detection).
Vaccination with a live vaccine within 30 days before the first dose (Cycle 1, Day 1).
Note: Inactivated injectable vaccines for seasonal influenza are permitted within 30 days before the first dose; live attenuated influenza vaccine administered intranasally is not allowed.
Presence of any serious or uncontrolled systemic disease, for example:
Clinically significant and severe, difficult-to-control abnormalities in cardiac rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation.
Unstable angina pectoris, congestive heart failure, or chronic heart failure of NYHA Class ≥2.
Any arterial thrombotic, embolic, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months before study treatment.
Poorly controlled blood pressure (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
Active tuberculosis.
Active or uncontrolled infection requiring systemic therapy.
Clinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.
Liver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.
Poorly controlled diabetes mellitus (fasting blood glucose > 10 mmol/L).
Urinalysis showing proteinuria ≥ 2+, with confirmed 24-hour urine protein > 1.0 g.
Psychiatric disorders that prevent the patient from cooperating with treatment.
History or evidence of disease, treatment, or laboratory abnormalities that could interfere with the study results or prevent the subject from completing full participation in the study, or any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment, including potential risks that are not explicitly listed above.
출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06
댓글 기능은 아직 설정 전입니다 (관리자: docs/SETUP.md의 giscus 항목 참고). 의견은 GitHub Discussions에 남겨 주세요.