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

Last updated: April 23, 2025
Sponsor: Qilu Pharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Gastric Ulcers

Adenocarcinoma

Stomach Cancer

Treatment

Capecitabine Tablets

Oxaliplatin Injection

QL2107 Injection

Clinical Study ID

NCT06942767
QLS31905-203
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects with unresectable locally advanced or metastatic gastric orgastroesophageal junction (GEJ) adenocarcinoma confirmed by histopathological orcytological examination;

  • Subjects with at least one measurable lesion designated as a target lesion, asassessed by the investigator according to RECIST v1.1. Lesions that have receivedradiotherapy or other local treatments may be considered measurable if theydemonstrate imaging PD;

  • No prior systemic anti-tumor treatment for locally advanced or metastatic gastric orgastroesophageal junction (GEJ) adenocarcinoma.

Exclusion

Exclusion Criteria:

  • Subjects with a known history of severe or repeated allergy, intolerance, orcontraindication to QLS31905, QL2107, or other large molecule protein preparations,as well as Oxaliplatin Injection or Capecitabine Tablets and any components in theirpreparations;

  • Subjects had other second primary malignancies within 5 years prior to the firstdose;

  • Subjects with clinically significant hemorrhage within 3 months before the firstdose

Study Design

Total Participants: 100
Treatment Group(s): 4
Primary Treatment: Capecitabine Tablets
Phase: 2
Study Start date:
June 01, 2025
Estimated Completion Date:
March 31, 2028

Study 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.