Actively Recruiting
Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2026-03-10
72
Participants Needed
16
Research Sites
190 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of LM-108 ± Penpulimab+Chemotherapy in Advanced Solid Tumors - Cohort C
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or above
- Eastern Cooperative Oncology Group (ECOG) physical fitness status score of 0-1
- At least one measurable tumor lesion
- All acute toxic reactions from prior anti-tumor treatments or surgery relieved to grade 0-1 or as specified
- Sufficient organ and bone marrow function
- Expected survival of at least 12 weeks
- Women infertile by menopause or bilateral oophorectomy; males and fertile females must agree to use approved contraception during the study and specified periods after treatment
- Negative serum pregnancy test within 3 days before starting study medication and not lactating
- Signed informed consent
- Pathological diagnosis of pancreatic cancer with advanced or metastatic disease that is unresectable
- No prior systemic treatment for unresectable locally advanced or metastatic pancreatic cancer
You will not qualify if you...
- Known high-frequency microsatellite instability (MSI-H) or deficient mismatch repair (dMMR)
- Uncontrolled or symptomatic active central nervous system metastasis
- Uncontrolled pleural effusion or ascites within 14 days before enrollment
- Unresolved biliary obstruction or less than 14 days stable after biliary stent placement
- Weight loss over 20% or BMI less than 18 kg/m² within 2 months before enrollment
- Prior treatment with CCR8 antibodies, CTLA-4 antibodies, or other Treg-targeting drugs
- Major surgery within 28 days before enrollment
- Use of immunosuppressive drugs within 14 days before enrollment
- Live attenuated vaccine administered within 28 days before enrollment or planned during study and 60 days after study drug completion
- Anti-tumor therapy within 28 days before enrollment
- Diagnosis of other malignant tumors within 5 years before enrollment
- Active or suspected autoimmune diseases
- Significant bleeding or thrombotic events within specified recent periods
- Severe or unhealed wounds, active ulcers, untreated fractures
- Peripheral neuropathy grade greater than 1
- Recent gastrointestinal perforation, fistula, obstruction, or related symptoms
- Interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases
- Known allergy to study drugs or severe reactions to monoclonal antibodies
- HIV infection, AIDS, untreated hepatitis or co-infections
- Uncontrolled heart conditions
- Recent systemic antibiotic use or unexplained fever
- History of organ or stem cell transplantation
- Participation in other drug trials within 4 weeks or insufficient washout
- History of substance abuse
- Other serious illnesses or abnormalities increasing risk or interfering with study, or deemed unsuitable by researchers
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Not Yet Recruiting
2
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
Not Yet Recruiting
3
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
4
Chongqing Qeneral Hospital
Chongqing, Chongqing Municipality, China, 400013
Not Yet Recruiting
5
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
Not Yet Recruiting
6
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
7
Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
8
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
9
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
10
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
11
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
12
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China, 110002
Not Yet Recruiting
13
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
14
The First Affiliated Hospital of Naval Medical University
Shanghai, Shanghai Municipality, China, 200336
Not Yet Recruiting
15
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
16
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300000
Not Yet Recruiting
Research Team
L
Lin Shen, Doctor
CONTACT
J
Jihui Hao, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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