New combo therapy aims to fight tough pancreatic cancer
NCT ID NCT06821503
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called LM-108, given with an immunotherapy (penpulimab) and two chemotherapy drugs, in people with advanced pancreatic cancer. The goal is to see if the combination is safe and can shrink tumors or slow the disease. About 72 adults with advanced pancreatic cancer will take part.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LM-108 (a monoclonal antibody that clears certain immune cells) plus penpulimab (an immunotherapy) plus chemotherapy (albumin-bound paclitaxel and gemcitabine)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced pancreatic cancer by combining immunotherapy with chemotherapy.
- What could go wrong
- This is an early-phase trial with only 72 participants, so results may not apply to all patients. The combination may cause serious side effects or fail to improve outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
16 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Cancer Hospital
RECRUITINGBeijing, Beijing Municipality, 100142, China
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Cancer Hospital Chinese Academy of Medical Science
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100021, China
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Chongqing Qeneral Hospital
NOT_YET_RECRUITINGChongqing, Chongqing Municipality, 400013, China
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Harbin Medical University Cancer Hospital
NOT_YET_RECRUITINGHarbin, Heilongjiang, 150081, China
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Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITINGWuhan, Hubei, 430000, China
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Jiangsu Cancer Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Jiangsu Provincial People's Hospital
NOT_YET_RECRUITINGNanjing, Jiangsu, 210000, China
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Peking Union Medical College Hospital
NOT_YET_RECRUITINGBeijing, Beijing Municipality, 100005, China
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The First Affiliated Hospital of China Medical University
NOT_YET_RECRUITINGShenyang, Liaoning, 110000, China
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The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITINGNanchang, Jiangxi, 330006, China
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The First Affiliated Hospital of Naval Medical University
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200336, China
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The First Affiliated Hospital of Xi'an Jiaotong University Medical College
NOT_YET_RECRUITINGXi'an, Shaanxi, 710000, China
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The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITINGZhengzhou, Henan, 450000, China
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The Sixth People's Hospital of Shenyang
NOT_YET_RECRUITINGShenyang, Liaoning, 110002, China
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Tianjin Cancer Hospital Airport Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300000, China
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Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Personalized drug matching put to the test in pancreatic cancer
- Can engineered immune cells tackle Hard-to-Treat KRAS cancers?
- Can a new injection boost chemotherapy against pancreatic cancer?
- Can a targeted antibody slow advanced pancreatic cancer?
- New Antibody-Drug combo takes on Hard-to-Treat pancreatic cancer
- New drug targets Hard-to-Treat pancreatic cancer by hitting a common mutation