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This is a phase III, Multicenter, Randomized study, evaluating the efficacy and Safety of LM-108(an Anti-CCR8 mAb) in combination With Toripalimab Versus Paclitaxel Injection in subjects with CCR8-Positive locally advanced or metastatic Gastric Cancer and Gastroesophageal Junction Adenocarcinoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-108 in combination with Toripalimab | Experimental |
| |
| Paclitaxel injection intravenous infusion | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-108 in combination with Toripalimab | Drug | LM-108 combined with Toripalimab administered intravenously on Day 1 every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS was defined as the time from date of randomization until death from any cause | up to 42 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengmeng Liu | Contact | +86 13918118040 | mengmengliu@lanovamed.com | |
| Paul Kong | Contact | +86 13564682439 | paulkong@lanovamed.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Shen | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| Paclitaxel injection intravenous infusion | Drug | Paclitaxel injection administered at a dose of 80 mg/m² on Day 1, 8, and 15 every 4 weeks |
|
ORR is defined as the proportion of subjects achieving the best overall response (BOR) of CR or PR. BOR refers to the best response recorded during the period from the date of randomization to the date of objective progression documented according to RECIST 1.1 criteria or the date of initiation of subsequent antitumor therapy (whichever occurs first).
| up to 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 from initial response (CR or PR) to date of documented disease progression or death (due to any cause) whichever occurs first, up to 42 months |
| Disease control rate (DCR) | defined as the proportion of participants who achieved CR, PR, or stable disease (SD) , based on Investigator assessment. | From start of treatment to date of documented disease progression, up to approximately 42 months |
| Incidence of adverse events (AEs) | up to 42 months |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
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