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Not yet recruiting NCT06942767

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

Phase II Interventional Gastric Adenocarcinoma Gastroesophageal Junction Adenocarcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLS31905 for Injection, QL2107 Injection, Oxaliplatin Injection, Capecitabine Tablets.
Who it may be relevant to
Registry conditions: Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug QLS31905 for Injection
    QLS31905 for Injection
  • Drug QL2107 Injection
    QL2107 Injection
  • Drug Oxaliplatin Injection
    Oxaliplatin Injection
  • Drug Capecitabine Tablets
    Capecitabine Tablets

Primary outcome measures

  • DLT [Time frame: up to 42 days following first dose]
  • MTD [Time frame: up to 42 days following first dose]
  • ORR (Objective Response Rate) [Time frame: Approximately 24 months]
Secondary outcome measures (7)
  • AE (adverse events) [Time frame: Approximately 24 months]
  • Number of anti-drug antibody (ADA) Positive Participants [Time frame: Approximately 24 months]
  • DOR (Duration of Response) [Time frame: Approximately 24 months]
  • PFS (Progression Free Survival) [Time frame: Approximately 24 months]
  • OS (Overall Survival) [Time frame: Approximately 24 months]
  • Maximum concentration (Cmax) [Time frame: Approximately 24 months]
  • Terminal elimination half-life (T1/2) [Time frame: Approximately 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06942767 · QLS31905-203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗