Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C
NCT ID: NCT06821503
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2025-02-28
2028-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LM-108 injection+penpulimab injection+Albumin paclitaxel+Gemcitabine
LM-108 injection+Penpulimab injection+Paclitaxel for injection (albumin bound)+Gemcitabine hydrochloride for injection, with a cycle of 28 days.
LM-108 injection
LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.
Penpulimab injection
Penpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor.
Paclitaxel for injection (albumin bound)
Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug
Gemcitabine hydrochloride for injection
Gemcitabine hydrochloride for injection is a cell cycle specific anti-tumor drug that can inhibit the growth of tumor cells and belongs to a type of chemotherapy drug.
LM-108 injection+Albumin paclitaxel+Gemcitabine
LM-108 injection+paclitaxel for injection (albumin bound type)+gemcitabine hydrochloride for injection, with a cycle of 28 days.
LM-108 injection
LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.
Paclitaxel for injection (albumin bound)
Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug
Gemcitabine hydrochloride for injection
Gemcitabine hydrochloride for injection is a cell cycle specific anti-tumor drug that can inhibit the growth of tumor cells and belongs to a type of chemotherapy drug.
Interventions
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LM-108 injection
LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.
Penpulimab injection
Penpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor.
Paclitaxel for injection (albumin bound)
Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug
Gemcitabine hydrochloride for injection
Gemcitabine hydrochloride for injection is a cell cycle specific anti-tumor drug that can inhibit the growth of tumor cells and belongs to a type of chemotherapy drug.
Eligibility Criteria
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Inclusion Criteria
* The Eastern Cooperative Oncology Group (ECOG) physical fitness status score is 0-1 points.
* There should be at least one measurable lesion.
Exclusion Criteria
* 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 diagnosed with Pancreatic ductal adenocarcinoma (PDAC) by pathology have evidence of advanced stage or metastasis that cannot be surgically removed.
* Have not received systematic treatment for unresectable locally advanced or metastatic PDAC in the past
* 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:
1. 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.
2. Having undergone major surgery within 28 days prior to enrollment.
3. Used immunosuppressive drugs within 14 days prior to enrollment.
4. 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.
5. 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.
18 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Chongqing Qeneral Hospital
Chongqing, Chongqing Municipality, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi'an, Shaanxi, China
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LM-108-Ib/II-01-C
Identifier Type: -
Identifier Source: org_study_id
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