LM-302
DrugLM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle
NCT Number: NCT06351020
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
This study is active but is not currently recruiting participants.
Notify Me18 year–80 year
All sexes
Interventional
Phase 3
Peking Union Medical College Hospital, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: up to 42 months
OS was defined defined as the time from date of randomization until death from any cause.
Time frame: up to 42 months
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: From start of treatment to date of documented disease progression, up to approximately 42 months
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: 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
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: From start of treatment to date of documented disease progression, up to approximately 42 months
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 signing the ICF until 28 days after EOT or accept other anti-cancer therapy,up to 40 days after last study dose
Adverse events will be graded according to the National Cancer Institute-Common Terminology Criteria for Adverse Events Version 5.0
Time frame: up to 42 months
Anti-drug antibody (ADA) will be detected, the titer of ADA will be evaluated using the validated assay.
Time frame: up to 42 months
Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Trough concentration will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Trough concentration will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Area under the plasma concentration versus time curve (AUC) will be evaluated using PopPK model and simulation.
Time frame: up to 42 months
Trough concentration will be evaluated using PopPK model and simulation.
LaNova Medicines Zhejiang Co., Ltd.
Industry
A Phase III, Open-Label, Multi Center, Randomized Study of LM-302 Versus Treatment of Physician's Choice (TPC) in Patients With CLDN18.2-Positive, Locally Advanced or Metastatic Gastric(GC) and Gastroesophageal Junction(GEJ) Adenocarcinoma.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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Locally Advanced or Metastatic GC and GCJ Adenocarcinoma
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