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
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Beijing Cancer Hospital
RECRUITING
Beijing
Cancer Hospital Chinese Academy of Medical Science
NOT_YET_RECRUITING
Beijing
Peking Union Medical College Hospital
NOT_YET_RECRUITING
Beijing
Chongqing Qeneral Hospital
NOT_YET_RECRUITING
Chongqing
Harbin Medical University Cancer Hospital
NOT_YET_RECRUITING
Harbin
The First Affiliated Hospital of Nanchang University
NOT_YET_RECRUITING
Nanchang
Jiangsu Cancer Hospital
NOT_YET_RECRUITING
Nanjing
Jiangsu Provincial People's Hospital
NOT_YET_RECRUITING
Nanjing
The First Affiliated Hospital of Naval Medical University
NOT_YET_RECRUITING
Shanghai
The First Affiliated Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Sixth People's Hospital of Shenyang
NOT_YET_RECRUITING
Shenyang
Tianjin Cancer Hospital Airport Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
Huazhong University of Science and Technology Tongji Medical College of Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University Medical College
NOT_YET_RECRUITING
Xi'an
The First Affiliated Hospital of Zhengzhou University