LM-108 with penpulimab plus albumin-bound paclitaxel and gemcitabine for advanced pancreatic cancer (Cohort C)

An Open Label Phase Ib/II Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab Plus Chemotherapy in Patients With Advanced Solid Tumors - Cohort C

This study will test whether adding LM-108 to penpulimab with albumin-bound paclitaxel and gemcitabine helps people with advanced pancreatic cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, penpulimab
• Locations: 16 sites (Beijing, Beijing Municipality and 15 other locations)
• Trial ID: NCT06821503 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label Phase Ib/II cohort examines LM-108 combined with penpulimab (an anti–PD-1 antibody) plus albumin-bound paclitaxel and gemcitabine in patients with advanced pancreatic cancer. Phase Ib is used to identify the recommended dose and characterize safety and tolerability, and Phase II explores preliminary anti-tumor activity. Eligible patients must have at least one measurable lesion, ECOG 0–1, adequate organ and bone marrow function, and an expected survival of at least 12 weeks. Treatments are given by intravenous infusion on scheduled cycles and patients must attend visits at one of the participating Beijing centers.

Who should consider this trial

Good fit: Adults with advanced pancreatic cancer who have measurable disease, ECOG performance status 0–1, adequate organ and bone marrow function, and an expected survival of at least 12 weeks are ideal candidates.

Not a fit: Patients with poor performance status (ECOG ≥2), inadequate organ function, uncontrolled comorbidities, active infections, or pregnancy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this combination could improve tumor control or extend the time without disease worsening compared with standard chemotherapy alone.

How similar studies have performed: Nab-paclitaxel plus gemcitabine is an established regimen, while adding PD-1 antibodies has shown limited benefit in pancreatic cancer to date, and LM-108 is a novel agent with limited published clinical data.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 15 other locations

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Chongqing Qeneral Hospital — Chongqing, Chongqing Municipality, China (Not_yet_recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• The Sixth People's Hospital of Shenyang — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University Medical College — Xi'an, Shaanxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Naval Medical University — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Lin Shen, Doctor

Conditions Advanced Pancreatic Cancer