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.
Study ID
NCT06942767
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QLS31905 for Injection — DRUG
    QLS31905 for Injection
  • QL2107 Injection — DRUG
    QL2107 Injection
  • Oxaliplatin Injection — DRUG
    Oxaliplatin Injection
  • Capecitabine Tablets — DRUG
    Capecitabine Tablets

Study Details

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.

Key Dates

First listed
Apr 24, 2025
Start date
Jun 30, 2025
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: QLS31905+QL2107+ XELOX
    QLS31905+QL2107+ oxaliplatin + capecitabine

Primary Outcome Measure

DLT [ Time Frame: up to 42 days following first dose ]

Central Contacts

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