Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - 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
1 other identifier
interventional
72
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2025
Typical duration for phase_1
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2025
CompletedFirst Posted
Study publicly available on registry
February 12, 2025
CompletedStudy Start
First participant enrolled
April 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
March 10, 2026
December 1, 2025
2.6 years
January 21, 2025
March 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Secondary Outcomes (3)
Overall survival (OS)
Up to 96 weeks
Duration of Response (DOR)
Up to 48 weeks
Overall response rate (ORR)
Up to 48 weeks
Study Arms (2)
LM-108 injection+penpulimab injection+Albumin paclitaxel+Gemcitabine
EXPERIMENTALLM-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
EXPERIMENTALLM-108 injection+paclitaxel for injection (albumin bound type)+gemcitabine hydrochloride for injection, with a cycle of 28 days.
Interventions
Penpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor.
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 is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.
Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug
Eligibility Criteria
You may qualify 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.
You may not qualify 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 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.
- 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:
- 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.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
Chongqing Qeneral Hospital
Chongqing, Chongqing Municipality, 400013, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110000, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, 110002, China
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi'an, Shaanxi, 710000, China
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, 200336, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2025
First Posted
February 12, 2025
Study Start
April 11, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
March 10, 2026
Record last verified: 2025-12