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

NCT06942767 | Not Yet Recruiting Phase 2

• 1 other identifier: QLS31905-203
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastric Adenocarcinoma; Gastroesophageal Junction Adenocarcinoma

Keywords

CLDN18.2, gastric or gastroesophageal junction (GEJ) adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• DLT

  Dose Limiting Toxicity，for Dose Escalation Stage

  up to 42 days following first dose

• MTD

  Maximum Tolerated Dose，for Dose Escalation Stage.

  up to 42 days following first dose

• ORR (Objective Response Rate)

  ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator per RECIST 1.1

  Approximately 24 months

Secondary Outcomes (7)

• AE (adverse events)

  Approximately 24 months

• Number of anti-drug antibody (ADA) Positive Participants

  Approximately 24 months

• DOR (Duration of Response)

  Approximately 24 months

• PFS (Progression Free Survival)

  Approximately 24 months

• OS (Overall Survival)

  Approximately 24 months

Study Arms (1)

QLS31905+QL2107+ XELOX

EXPERIMENTAL

QLS31905+QL2107+ oxaliplatin + capecitabine

Drug: QLS31905 for Injection; Drug: QL2107 Injection; Drug: Oxaliplatin Injection; Drug: Capecitabine Tablets

Interventions

QLS31905 for Injection DRUG

QLS31905 for Injection

QLS31905+QL2107+ XELOX

QL2107 Injection DRUG

QL2107 Injection

QLS31905+QL2107+ XELOX

Oxaliplatin Injection DRUG

Oxaliplatin Injection

QLS31905+QL2107+ XELOX

Capecitabine Tablets DRUG

Capecitabine Tablets

QLS31905+QL2107+ XELOX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Adenocarcinoma

Interventions

Injections; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Lin Shen, PHD

CONTACT

010-881965671; linshenpku@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2028
• Last Updated: April 27, 2025

Record last verified: 2025-04