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진행성 고형암 환자를 위한 DM002 연구

A Study of DM002 in Patients With Advanced Solid Tumors

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 NCT06751329
상태 모집 중
단계 1상/2상
시험 약물/중재 DM002
대상 질환 Ovarian Neoplasms, Prostatic Neoplasms, Endometrial Neoplasms, Colorectal Neoplasms, Solid Carcinoma, Pancreatic Cancer
스폰서 Xadcera Biopharmaceutical (Suzhou) Co., Ltd.
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 280
시작 / 1차 완료 예정 2025-02-17 / 2027-10-08
국내 실시기관 없음
실시 국가 2개국, 기관 7곳 (Australia, United States)
결과 게시 아니오
최근 갱신 2026-08-07

시험 개요

이 연구는 진행성 고형암(solid tumor) 환자를 대상으로 이중특이적 항체-약물 접합체(antibody-drug conjugate, ADC)인 DM002의 안전성과 약동학 등을 평가하기 위한 임상 1/2상 시험입니다. 1부 용량 증량(dose escalation) 단계에서는 소수의 환자에게 가장 낮은 용량부터 투여하며 안전성을 확인하고 적정 용량을 찾습니다. 2부 용량 확장(dose expansion) 단계에서는 결정된 최적 용량으로 환자들에게 투여하여 안전성과 약물 반응을 평가합니다. 총 목표 인원은 280명이며 국내 기관은 0곳입니다.

  • 임상 단계는 1/2상(PHASE1/PHASE2)이며, 목표 인원은 280명입니다.
  • 대상 질환은 난소암, 전립선암, 자궁내막암, 대장암 및 기타 고형암(Solid Carcinoma)입니다.
  • DM002는 MUC1과 HER3를 표적으로 하는 이중특이적 항체-약물 접합체(ADC)입니다.
  • 국내 기관은 초록에 명시되지 않음.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 만 18세 이상 성인 - 동유럽종양학그룹(ECOG) 수행 상태 평가 0, 1 또는 2 - 기대 여명 3개월 이상 - 적절한 골수, 신장 및 간 기능 수치 유지 - RECIST 버전 1.1에 따른 측정 가능한 병변 존재 - 이전 3년 이내에 획득한 종양 조직 검체 제공 가능. 제외 기준: - 5년 이내에 다른 활성 침습성 악성 종양 병력 - 혈액암의 현재 또는 과거 병력 - 첫 연구 약물 투여 전 28일 이내 또는 5반감기 이내의 항암 치료 - 원발성 중추신경계(CNS) 악성 종양 또는 뇌转移(전이) - ADC 또는 토포이섬라제 I(Topo I) 페이로드가 포함된 ADC 치료 경험.

선정/제외 기준 원문 (영어)

Inclusion Criteria:

Common Inclusion Criteria (Part 1 and Part 2)

  1. Subjects must have the ability to understand and willingness to sign a written informed consent document.
  2. Subjects must be ≥18 years of age at the time of signing the informed consent form.
  3. Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
  4. Has a life expectancy of ≥3 months.
  5. Participants must meet the following laboratory values within 7 days prior to first dose of study drug:

Note: Transfusion (red blood cell or platelet) or granulocyte-colony stimulating factor (G-CSF) administration is not allowed within 2 weeks prior to laboratory assessments at Screening. * Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; * Platelet count ≥100 × 10⁹/L; * Hemoglobin ≥9 g/dL; * Calculated creatinine clearance (CrCL) >60 mL/min (Cockroft-Gault Equation); * Total bilirubin ≤ 1.5 x ULN; * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × upper limit of normal (ULN), if liver metastases are present, ≤5 × ULN; * International normalized ratio (INR)\<2.0, and prothrombin time and either partial thromboplastin time (PTT) or activated PTT (aPTT) ≤1.5 × ULN, except for participants receiving anti-vitamin K derivative anticoagulant therapy who must have prothrombin time/INR within therapeutic range as deemed appropriate by the Investigator. 6. Has measurable disease based on RECIST version 1.1. 7. Participants are required to provide tumor tissue specimens obtained within the previous 3 years for the measurement of MUC1 and/or HER3 and other biomarkers. For those subjects who are unable to provide tissue samples will be encouraged (but not mandatory) to undergo biopsy if the risk is manageable. If the biopsy is not possible, it should inform the sponsor for enrolment.

Exclusion Criteria:

  1. Subjects have another active invasive malignancy within 5 years, with the following exceptions and notes:

  2. History of noninvasive malignancy, such as cervical cancer in situ, in situ melanoma, or ductal carcinoma in situ of the breast that is in complete remission 5 years after treatment with curative intent is allowed.

  3. Malignancies with a negligible risk of metastasis or death (such as adequately treated basal or squamous cell skin cancer and localized prostate cancer).
  4. Current or history of a hematologic malignancy.
  5. Anticancer therapy (chemotherapy, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, or other anti-cancer therapies, except for hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels) within 28 days or 5 half-lives, whichever is shorter, prior to the first study dose. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first study dose. Major surgery, other than diagnostic surgery, within 4 weeks of the first study dose.
  6. Primary central nervous system (CNS) malignancies or CNS metastases. Individuals with brain metastases can be enrolled only if treated, nonprogressive brain metastases and off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks.
  7. History of known allergies to ADC, or prior discontinuation of an ADC due to treatment-related toxicities. Has received prior treatment with ADCs that include topoisomerase I (Topo I) payload, and treatment history with any investigational drug within 4 weeks before enrolment in the study.
  8. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals.
  9. Has a pre-existing clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or pre-existing ocular disorders.
  10. Clinically uncontrolled intercurrent illness, including but not limited to an ongoing active infection, active coagulopathy, uncontrolled cardiovascular disease, uncontrolled immune disease, uncontrolled diabetes, uncontrolled pleural and peritoneal effusion, psychiatric illness that would limit compliance with the study requirements and other serious medical illnesses requiring systemic therapies.
  11. Mean resting corrected QT interval corrected by Fridericia's formula (QTcF) >470 msec obtained from triplicate 12-lead ECGs at baseline; using concomitant medications that would prolong the QT interval.
  12. Left ventricular ejection fraction \<50% by either an echocardiogram (ECHO) or a multi-gated acquisition scan within 28 days before first dose of the study drug.
  13. Known active hepatitis B (HBV) or hepatitis C (HCV) infection. Chronic carriers of HBV infection (HBsAg-positive, undetectable HBV DNA or HBV DNA ≤2500 copies/ml or 500 IU/ml) receive prophylactic treatment during the study can be enrolled. Participants with a history of HCV infection have completed curative antiviral treatment and HCV viral load below the limit of quantification and HCV antibody positive but HCV ribonucleic acid (RNA) negative due to prior treatment or natural resolution should be eligible.
  14. Known human immunodeficiency virus (HIV) infection which is not well controlled. Participants should be tested for HIV prior to enrollment if required by local regulations or institutional review board (IRB)/ethics committee. All the following criteria are required to define an HIV infection (positive HIV1/2 antibodies test) that is well controlled: HIV viral load \<400 copies/mL, CD4+ T- cell counts ≥350 cells/μL, no history of acquired immunodeficiency syndrome-defining opportunistic infection within the past 12 months, and stable viral load for at least 4 weeks on same anti-HIV retroviral medications.
  15. Subjects who are from endemic areas (refer to WHO high tuberculosis burden country list, China is endemic area) will be specifically screened for tuberculosis with any available test. Subjects with active tuberculosis are excluded. Subjects who have received bacille Calmette-Guerin vaccination may have a false positive result of purified-protein derivative (PPD) test. These subjects are eligible if they have a negative result of interferon gamma release assay (IGRA).
  16. Has received a live vaccine within 30 days prior to the first dose of study drug.
  17. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia and anemia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, ≤Grade 1 or baseline. Note: Participants may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to >Grade 2 for at least 3 months prior to enrolment/randomization and managed with the standard treatment) that the Investigator deems related to previous anticancer therapy, following discussion with the Sponsor's medical monitor, such as the following: Grade 2 chemotherapy-induced neuropathy, hypothyroidism, hyperglycemia.
  18. Females who are pregnant or lactating or who intend to become pregnant during participation in the study are not eligible to participate.
  19. Participants who are of reproductive potential refuse to use effective methods of birth control during participation of the study and within 7 months for female (and 4 months for male) after the last dose administration.
  20. Participants who took drugs or food which can strongly inhibit or induce the cytochrome P450 (CYP) isoenzyme, CYP3A4/5 within 2 weeks prior to the first dose of DM002 or within 5 half-lives, whichever is longer.

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

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