진행성 고형암 환자에서 LM-108 및 Penpulimab과 항암화학요법 병용요법의 안전성, 내인성, 예비 유효성을 평가하는 임상시험 (코호트 C)¶

Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C

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	NCT06821503
상태	모집 중
단계	1상/2상
시험 약물/중재	LM-108 injection, Penpulimab injection, Paclitaxel for injection (albumin bound), Gemcitabine hydrochloride for injection
대상 질환	Advanced Pancreatic Cancer
스폰서	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	72
시작 / 1차 완료 예정	2025-04-11 / 2027-12
국내 실시기관	없음
실시 국가	1개국, 기관 16곳 (China)
결과 게시	아니오
최근 갱신	2026-03-10

문의처 (등록된 중앙 연락처)¶

Lin Shen, Doctor 13911219511 doctorshenlin@sina.cn
Jihui Hao, Doctor 18622221120 haojihui@tjmuch.com

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

시험 개요¶

이 임상시험은 진행성 췌장암(Advanced Pancreatic Cancer) 환자를 포함한 진행성 고형암 환자를 대상으로 LM-108, penpulimab, 맙테라 계열의 약물 등을 병용하는 제1b/2상 연구입니다. 1b상에서는 용량을 결정하고, 2상에서는 진행성 췌장암 환자에 대한 유효성과 안전성을 탐색합니다. 목표 인원은 총 72명입니다. 초록에 세부 유효성 및 생존기간 결과는 명시되지 않았습니다.

목표 환자 수는 총 72명입니다.
대상 질환은 수술 불가능한 진행성 또는 전이성 췌장암이며, 이전에 전신 치료를 받은 적이 없는 환자를 대상으로 합니다.
임상시험 단계는 제1b/2상(PHASE1/PHASE2)입니다.
구체적인 유효성 및 생존기간 수치는 초록에 명시되지 않았습니다.

참여 조건 (AI 정리, 원문 확인 필요)¶

선정 기준: * 나이가 만 18세 이상인 환자 * ECOG 신체 상태 점수가 0~1점인 환자 * 적어도 하나의 측정 가능한 병변이 있는 환자 * 예상 생존 기간이 12주 이상인 환자 * 췌장암(관선암 또는 선암)의 병리적 진단을 받고 절제할 수 없는 진행성 또는 전이성 질환의 증거가 있는 환자 * 절제 불가능한 국소 진행성 또는 전이성 췌장암에 대해 이전에 전신 치료를 받은 적이 없는 환자

제외 기준: * 고빈도 현미부수체 불안정성(MSI-H) 또는 불일치 복구 결함(dMMR)이 있는 경우 * 조절되지 않거나 증상이 있는 활성 중추신경계 전이가 있는 경우 * 등록 전 28일 이내에 항암 치료를 받은 적이 있는 경우 * 5년 이내에 다른 악성 종양 진단을 받은 적이 있는 경우 * 간염, HIV 등 감염성 질환이 있는 경우

선정/제외 기준 원문 (영어)

Inclusion Criteria:

Age 18 or above.
The Eastern Cooperative Oncology Group (ECOG) physical fitness status score is 0-1 points.
There should be at least one measurable lesion.
All acute toxic reactions caused by previous anti-tumor treatments or surgical procedures have been relieved to grade 0-1 or to the levels specified in the inclusion/exclusion criteria.
Have sufficient organ and bone marrow function
Expected survival period ≥ 12 weeks
Infertility is defined as women who have reached menopause or have undergone bilateral oophorectomy with medical records. Male participants and female participants with fertility must agree to use one medically approved contraceptive measure during the trial period and within 6 months after the last administration of the trial drug or within 9 months after the last administration of chemotherapy drug (oxaliplatin) (whichever is later). The serum pregnancy test must be negative within 3 days before starting the study medication and not during lactation.
With my consent and signed informed consent form.
Patients with a pathological diagnosis of pancreatic cancer (ductal adenocarcinoma or adenocarcinoma) have evidence of advanced or metastatic disease that is not resectable.
Previously received no systemic treatment for unresectable locally advanced or metastatic pancreatic cancer.

Exclusion Criteria:

Known High-frequency microsatellite instability (MSI-H)/deficient mismatch repair (dMMR).
There is uncontrolled or symptomatic active central nervous system metastasis, which can manifest as clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, leptomeningeal disease, and/or progressive growth.
Within 14 days prior to enrollment, there were still uncontrollable pleural effusion and ascites despite treatment such as puncture and drainage; Pericardial effusion accompanied by clinical symptoms or moderate or above.
Within 14 days prior to enrollment, there is an unresolved biliary obstruction, or the clinical status has remained stable for less than 14 days after biliary stent implantation.
Participants' weight has decreased by more than 20% or their body mass index (BMI) is less than 18 kg/m ² within the first 2 months of enrollment.
Received the following treatments or medications before enrollment:
Prior to enrollment, received treatment with C-C chemokine Receptor 8 (CCR8) antibodies, cytotoxic T-lymphocyte associated protein-4 (CTLA-4) antibodies, or other drugs that act on Tregs.
Having undergone major surgery within 28 days prior to enrollment.
Used immunosuppressive drugs within 14 days prior to enrollment.
Vaccination with attenuated live vaccine should be administered within 28 days prior to enrollment or planned within the study period and 60 days after completion of study drug treatment.
Received anti-tumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biological therapy, or tumor embolization) within 28 days before enrollment.
Diagnosed with any other malignant tumor within the 5 years prior to enrollment.
There are any active, known or suspected autoimmune diseases present.
Within the first 3 months of enrollment, there have been significant clinical bleeding symptoms or clear bleeding tendencies; Arterial/venous thrombotic events that occurred within the first 6 months of enrollment.
Significant vascular disease occurred within the first 6 months of enrollment.
Severe, unhealed, or cracked wounds, as well as active ulcers or untreated fractures.
There is peripheral neuropathy of grade>1 present.
Have experienced gastrointestinal perforation and/or gastrointestinal fistula within the 6 months prior to enrollment;
Within the 6 months prior to enrollment, there have been clinical signs or symptoms of intestinal obstruction and/or gastrointestinal obstruction.
Existence of interstitial lung disease, non infectious pneumonia, or uncontrolled systemic diseases.
Known to be allergic to the investigational drug or any of its excipients; Or have experienced severe allergic reactions to other monoclonal antibodies.
Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis or co infection with hepatitis B and hepatitis C.
Clinical symptoms or diseases of the heart that have not been well controlled:
Systemic use of antibiotics for at least 7 days within the 28 days prior to enrollment, or unexplained fever>38.5 °C during screening/before first administration.
Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
Have participated in any other drug clinical studies within 4 weeks prior to enrollment, or have not had more than 5 half lives since the last study medication.
Known history of abuse or drug use of psychotropic substances.
There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the study results, as well as patients who the researcher deems unsuitable to participate in this study.

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

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