This study will assess the efficacy and safety of LM-302 Versus Treatment of Physician's Choice (TPC) in Subjects With locally advanced or metastatic, Claudin (CLDN) 18.2-positive, Gastric or Gastroesophageal Junction Adenocarcinoma who have progressed on or after 2 lines of systemic therapy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
387
LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle
The subjects will receive Apatinib orally,qd
The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Overall Survival (OS)
OS was defined defined as the time from date of randomization until death from any cause.
Time frame: up to 42 months
Progression Free Survival (PFS)
PFS was defined as the time from date of randomization until first objective radiographic tumor progression or death from any cause, based on Investigator assessment
Time frame: up to 42 months
Objective response rate (ORR)
defined as the proportion of participants who achieve a best response of complete response (CR) or partial response (PR) using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria as assessed by Investigator.
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
Duration of response (DoR)
defined time from the initial response (CR or PR) until documented tumor progression or death from any cause and based on Investigator assessment.
Time frame: Time from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to approximately 42 months
Disease control rate (DCR)
defined as the proportion of participants who achieved CR, PR, or stable disease (SD) for a minimum of 6 weeks during study treatment, based on Investigator assessment.
Time frame: From start of treatment to date of documented disease progression, up to approximately 42 months
AE and SAE
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0
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Time frame: From signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose
Evaluate the immunogenicity of LM-302
Anti-drug antibody (ADA) will be detected, the titer of ADA will be evaluated using the validated assay.
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of LM-302
Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of LM-302
Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of LM-302
Trough concentration will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of total antibody
Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of total antibody
Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of total antibody
Trough concentration will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of MMAE
Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of MMAE
Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Evaluation of pharmacokinetic characteristics of MMAE
Trough concentration will be evaluated using PopPK model and simulation.
Time frame: up to 42 months