BridgeMD
Tests treatment safety and results for Advanced Pancreatic Cancer
Official title Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C
ClinicalTrials.gov ID: NCT06821503
What this study is testing
What is LM-108 injection?
LM-108 injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced pancreatic cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is the cohort C part of a multicenter, open label Phase Ib/II clinical study evaluating the preliminary efficacy, safety, and tolerability of LM-108 combined with anti-tumor therapy in patients with advanced solid tumors. The dose of LM-108 combined with penpulimab, albumin paclitaxel, and gemcitabine is recommended in Phase Ib.Explore the efficacy and safety of LM-108 combined with anti-tumor therapy in patients with advanced pancreatic cancer in Phase II.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
- Previously received no systemic treatment for unresectable locally advanced or metastatic pancreatic cancer. Exclusion Criteria:
See the full eligibility 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/
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Chongqing, Chongqing Municipality, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Nanjing, Jiangsu, China
- Nanchang, Jiangxi, China
- Shenyang, Liaoning, China
- Xi'an, Shaanxi, China
- Shanghai, Shanghai Municipality, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Chongqing, Chongqing Municipality, China; Harbin, Heilongjiang, China; Zhengzhou, Henan, China; Wuhan, Hubei, China; Nanjing, Jiangsu, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.