LP002 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors. In this study, the safety, pharmacokinetics and preliminary efficacy of LP002 for the treatment of malignant digestive system neoplasms will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
94
600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W).
50mg/m2 IV on Day 1, Q2W
2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGHenan Cancer Hospital & Insititute
Zhengzhou, Henan, China
RECRUITINGHubei Cancer Hospital & Insititute
Wuhan, Hubei, China
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to approximately 24 months
Objective Response Rate (ORR) for Arm I-A, I-B, I-C, I-E
Percentage of subjects achieving complete response (CR) and partial response (PR). R0 resection rate RFS pCR
Time frame: up to approximately 24 months
Disease Control Rate (DCR) for Arm I-A, I-B, I-C, I-E
Disease Control Rate (DCR) refers to the proportion of subjects who achieve CR, PR and SD through imaging evaluation.
Time frame: up to approximately 24 months
Duration of Response (DOR) for Arm I-A, I-B, I-C, I-E
Duration of Response (DOR) is defined as the time from the first evidence of response (PR or CR) to the first evidence of PD or the date of death for any reason.
Time frame: up to approximately 24 months
Progression-Free Survival (PFS) for Arm I-A, I-B, I-C, I-E
Progression-free survival (PFS) is defined as the time from the first study drug treatment to disease progression (PD) or to death of the subject due to any reason.
Time frame: up to approximately 24 months
Overall survival (OS) for Arm I-A, I-B, I-C, I-D, I-E
Overall survival (OS) refers to the time from the first study drug treatment to death due to any cause.
Time frame: up to approximately 24 months
R0 resection rate for Arm I-D
R0 resection rate refers to the rate of patients who have achieved curative resection of the tumor.(Curative resection refers to the absence of tumor after surgical treatment. R0 resection indicates a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed.)
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106 or 107 or 108 CCID50/mL by intra-tumoral injection, Q2W
Liaoning Cancer Hospital & Insititute
Shenyang, Liaoning, China
RECRUITINGThe First Affiliated Hospital. Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
RECRUITINGThe First Affiliated Hospital. Zhejiang University School Of Medicine
Hangzhou, Zhejiang, China
RECRUITINGTime frame: up to approximately 12 months
pathological complete response rate (pCR rate)
pathological complete response rate (pCR rate) refers to the rate of patients whose tissue samples show no cancer cells left under a microscope after the anti-cancer treatment.
Time frame: up to approximately 12 months
Terminal half life of LP002
Time frame: up to approximately 12 months
Area under curve of LP002
Time frame: up to approximately 12 months
Apparent volume of distribution of LP002
Time frame: up to approximately 12 months
Systemic clearance of LP002
Time frame: up to approximately 12 months
Cmax of LP002
Time frame: up to approximately 12 months
Tmax of LP002
Time frame: up to approximately 12 months
Serum concentration of the antibody against LP002 within 1 hour prior to each administration
Time frame: up to approximately 24 months