Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-108 injection+penpulimab injection+Albumin paclitaxel+Gemcitabine | Experimental | LM-108 injection+Penpulimab injection+Paclitaxel for injection (albumin bound)+Gemcitabine hydrochloride for injection, with a cycle of 28 days. |
|
| LM-108 injection+Albumin paclitaxel+Gemcitabine | Experimental | LM-108 injection+paclitaxel for injection (albumin bound type)+gemcitabine hydrochloride for injection, with a cycle of 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-108 injection | Drug | LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Subjects appear the toxic reaction relate to the drug after treatment within 28 days. | Baseline up to 28 days |
| Progression-Free Survival (PFS) | PFS will be defined as median number of months from the date of randomization until the first documented sign of disease progression or death due to any causes, whichever occurs first. | Up to 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival defined as the time from enrollment to death from any cause. | Up to 96 weeks |
| Duration of Response (DOR) | DOR will be defined as median number of months from date of first documented objective response until first documented sign of disease progression or death due to any causes. |
Not provided
Inclusion Criteria:
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shen, Doctor | Contact | 13911219511 | doctorshenlin@sina.cn | |
| Jihui Hao, Doctor | Contact | 18622221120 | haojihui@tjmuch.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100005 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Penpulimab injection | Drug | Penpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor. |
|
| Paclitaxel for injection (albumin bound) | Drug | Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug |
|
| Gemcitabine hydrochloride for injection | Drug | 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. |
|
| Up to 48 weeks |
| Overall response rate (ORR) | Objective response rate refers to the percentage of complete response (CR) or partial response (PR) subjects determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST 1.1 for immune based therapeutics(iRECIST) (CR and PR under iRECIST criteria can occur after imaging disease progression). | Up to 48 weeks |
| Cancer Hospital Chinese Academy of Medical Science | Not yet recruiting | Beijing | Beijing Municipality | 100021 | China |
|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
|
| Chongqing Qeneral Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | 400013 | China |
|
| Harbin Medical University Cancer Hospital | Not yet recruiting | Harbin | Heilongjiang | 150081 | China |
|
| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
|
| Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology | Not yet recruiting | Wuhan | Hubei | 430000 | China |
|
| Jiangsu Cancer Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Jiangsu Provincial People's Hospital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
|
| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
|
| The First Affiliated Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
|
| The Sixth People's Hospital of Shenyang | Not yet recruiting | Shenyang | Liaoning | 110002 | China |
|
| The First Affiliated Hospital of Xi'an Jiaotong University Medical College | Not yet recruiting | Xi'an | Shaanxi | 710000 | China |
|
| The First Affiliated Hospital of Naval Medical University | Not yet recruiting | Shanghai | Shanghai Municipality | 200336 | China |
|
| Tianjin Cancer Hospital Airport Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300000 | China |
|
| Tianjin Medical University Cancer Institute & Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300000 | China |
|
| ID | Term |
|---|---|
| C000720860 | penpulimab |
| D017239 | Paclitaxel |
| D007267 | Injections |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided