Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587425
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-04
Brief Title:
The Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced Recurrent or Metastatic CLDN182-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination With Candonilimab and Capecitabine for First-Line Treatment in Patients With Unresectable Advanced Recurrent or Metastatic CLDN182-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase II Study Evaluating the Efficacy and Safety of LM-302 in Combination with Candonilimab and Capecitabine for First-Line Treatment in Patients with Unresectable Advanced Recurrent or Metastatic CLDN182-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
Detailed Description:
The antibody-drug conjugate ADC targeting CLDN182 exerts its anti-tumor effects through multiple mechanisms including direct cytotoxicity to CLDN182-positive tumor cells via the delivery of a potent small-molecule toxin a bystander effect that induces cytotoxicity in adjacent CLDN182-negative tumor cells and the activation of the immune system through antibody-dependent cellular cytotoxicity ADCC The combination of this ADC with immune checkpoint inhibitors holds potential for synergistic anti-tumor activity LM-302 an ADC specifically targeting CLDN182 and comprising a monoclonal antibody conjugated to MMAE has demonstrated favorable efficacy and safety profiles in both preclinical and clinical studies for CLDN182-expressing gastrointestinal malignancies including gastric and gastroesophageal junction adenocarcinomas The combination of LM-302 with immune checkpoint inhibitors may offer enhanced clinical benefits for patients with advanced gastric cancer
This clinical study aims to evaluate the efficacy and safety of LM-302 ADC targeting Claudin182 in combination with cadonilimab a bispecific antibody targeting PD-1 and CTLA-4 and capecitabine as a first-line treatment in patients with unresectable recurrent or metastatic CLDN182-positive gastric or gastroesophageal junction adenocarcinoma
This clinical study aims to evaluate the efficacy and safety of LM-302 ADC targeting Claudin182 in combination with cadonilimab a bispecific antibody targeting PD-1 and CTLA-4 and capecitabine as a first-line treatment in patients with unresectable recurrent or metastatic CLDN182-positive gastric or gastroesophageal junction adenocarcinoma
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None