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NOT YET RECRUITING
NCT06942767
PHASE2

Combination of QLS31905, QL2107 and Chemotherapy as First-line Therapy in CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter Phase II clinical study aimed at evaluating the tolerability, safety, efficacy, PK profile, and immunogenicity of QLS31905 for Injection combined with QL2107 Injection and XELOX regimen in the first-line treatment of CLDN18.2-positive unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Official title: An Open-label, Multicenter Phase II Clinical Study of QLS31905 for Injection Combined With QL2107 Injection and XELOX Regimen in the First-line Treatment of CLDN18.2-positive Unresectable Locally Advanced or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-06

Completion Date

2028-03

Last Updated

2025-04-27

Healthy Volunteers

No

Interventions

DRUG

QLS31905 for Injection

QLS31905 for Injection

DRUG

QL2107 Injection

QL2107 Injection

DRUG

Oxaliplatin Injection

Oxaliplatin Injection

DRUG

Capecitabine Tablets

Capecitabine Tablets