Advanced Pancreatic Cancer
Conditions
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.
Interventions
DRUGLM-108 injection
LM-108 injection is a monoclonal antibody that selectively clears regulatory T cells that infiltrate tumor sites.
Penpulimab injection is a Programmed Cell Death Protein 1 (PD-1) immune checkpoint inhibitor.
Paclitaxel for injection (albumin bound) is a cytotoxic anticancer drug
DRUGGemcitabine hydrochloride for injection
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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | Baseline up to 28 days | Subjects appear the toxic reaction relate to the drug after treatment within 28 days. |
| Progression-Free Survival (PFS) | Up to 48 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 96 weeks | Overall survival defined as the time from enrollment to death from any cause. |
| Duration of Response (DOR) | Up to 48 weeks | 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. |
| Overall response rate (ORR) | Up to 48 weeks | 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). |
Countries
China
Contacts
CONTACTLin Shen, Doctor
CONTACTJihui Hao, Doctor
Outcome results
None listed