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

NCT ID: NCT06942767

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2028-03-31

Brief 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.

Detailed Description

QLS31905 is a bispecific antibody targeting CD3 and CLDN18.2 independently developed by Qilu Pharmaceutical Co., Ltd.

QL2107 is a biosimilar of pembrolizumab (Keytruda®) developed by Qilu Pharmaceutical Co., Ltd.

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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLS31905+QL2107+ XELOX

QLS31905+QL2107+ oxaliplatin + capecitabine

Group Type: EXPERIMENTAL

QLS31905 for Injection

Intervention Type: DRUG

QLS31905 for Injection

QL2107 Injection

Intervention Type: DRUG

QL2107 Injection

Oxaliplatin Injection

Intervention Type: DRUG

Oxaliplatin Injection

Capecitabine Tablets

Intervention Type: DRUG

Capecitabine Tablets

Interventions

QLS31905 for Injection

QLS31905 for Injection

Intervention Type: DRUG

QL2107 Injection

QL2107 Injection

Intervention Type: DRUG

Oxaliplatin Injection

Oxaliplatin Injection

Intervention Type: DRUG

Capecitabine Tablets

Capecitabine Tablets

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects with unresectable locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma confirmed by histopathological or cytological examination;
• Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD;
• No prior systemic anti-tumor treatment for locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Exclusion Criteria

• Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations;
• Subjects had other second primary malignancies within 5 years prior to the first dose;
• Subjects with clinically significant hemorrhage within 3 months before the first dose

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lin Shen, PHD

Role: CONTACT

linshenpku@163.com

010-881965671

Other Identifiers

QLS31905-203

Identifier Type: -

Identifier Source: org_study_id