Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-302 | Experimental | Patients will accept LM-302 monotherapy |
|
| Physician's choice Apatinib or Irinotecan | Active Comparator | Patients will accept Apatinib or Irinotecan monotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-302 | Drug | LM-302 intravenous-injection every 2 weeks on Day 1 of each 14-day cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS was defined defined as the time from date of randomization until death from any cause. | 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 | up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From start of treatment to date of documented disease progression, up to approximately 42 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Chunmei Bai | Peking Union Medical College Hospital | Principal Investigator |
| Jin Li | Shanghai East Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China | ||
| Shanghai East Hospital |
Not provided
experimental arm:LM-302 control arm:Apatinib or Irinotecan
Not provided
Not provided
Not provided
Not provided
| Apatinib |
| Drug |
The subjects will receive Apatinib orally,qd |
|
| Irinotecan | Drug | The subjects will receive Irinotecan intravenous-injection,every 2 weeks on Day 1 of each 14-day cycle |
|
| 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 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. | 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 | 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. | up to 42 months |
| Evaluation of pharmacokinetic characteristics of LM-302 | Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation. | 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. | up to 42 months |
| Evaluation of pharmacokinetic characteristics of LM-302 | Trough concentration will be evaluated using PopPK model and simulation. | up to 42 months |
| Evaluation of pharmacokinetic characteristics of total antibody | Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation. | 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. | up to 42 months |
| Evaluation of pharmacokinetic characteristics of total antibody | Trough concentration will be evaluated using PopPK model and simulation. | up to 42 months |
| Evaluation of pharmacokinetic characteristics of MMAE | Peak Plasma Concentration (Cmax) will be evaluated using PopPK model and simulation. | 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. | up to 42 months |
| Evaluation of pharmacokinetic characteristics of MMAE | Trough concentration will be evaluated using PopPK model and simulation. | up to 42 months |
| Shanghai |
| Shanghai Municipality |
| 200000 |
| China |
| ID | Term |
|---|---|
| C553458 | apatinib |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided