Evaluating Q-1802 with XELOX for treating gastrointestinal tumors

A Phase I/II Clinical Trial to Evaluate the Safety Tolerance and Initial Efficacy of Q-1802 Combined With Standard Treatment in Patients With Gastrointestinal Tumors

This study is testing if a new drug called Q-1802, when combined with the standard XELOX treatment, can help people with advanced stomach cancer that can't be surgically removed.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: QureBio Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05964543 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and efficacy of Q-1802 in combination with the XELOX regimen for patients with unresectable advanced or recurrent metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma. The study is designed as a multicenter, open-label trial that includes a dose escalation phase to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of Q-1802. Following this, a randomized controlled phase will compare the outcomes of patients receiving the combination treatment against those receiving XELOX alone, focusing on pharmacokinetics, pharmacodynamics, and immunogenicity profiles. Patients must have medium to high expression of Claudin18.2 in their tumor samples to qualify for participation.

Who should consider this trial

Good fit: Ideal candidates are patients with unresectable advanced or recurrent gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who express medium to high levels of Claudin18.2.

Not a fit: Patients who have received prior anti-tumor treatments or have low Claudin18.2 expression may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced gastrointestinal tumors that currently have limited treatment options.

How similar studies have performed: While this approach is novel in the context of combining Q-1802 with XELOX, similar studies have shown promise in targeting Claudin18.2 in gastrointestinal tumors.

Eligibility criteria

Inclusion criteria：

Patients with at least one measurable lesion per RECIST (v1.1);

Patients with medium or high expression of Claudin18.2 in tumor tissue samples tested by immunohistochemistry in central laboratory were included;

Patients with untreated, unresectable advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with negative HER-2 immunohistochemistry or FISH test (HER-2 immunohistochemistry 0/1+ confirmed by a qualified local or central laboratory, or 2+ confirmed negative by FISH test) were included;

Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening and no deterioration occurs within two weeks before enrollment;

Life expectancy period ≥ 12 weeks;

Patients who have sufficient baseline organ function.

Exclusion Criteria:

Receive anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the treatment drug, whichever is shorter;

Patients who have previously used Claudin 18.2 products for treatment;

With uncontrolled diseases;

Who are allergic to the study drug or any of its components;

Patients with a history of other primary malignant tumors at the time of screening, except for cured skin Basal-cell carcinoma or Cutaneous squamous-cell carcinoma or cervical Carcinoma in situ.

Where this trial is running

Beijing, Beijing

• Beijing cancer hospical — Beijing, Beijing, China (Recruiting)

Study contacts

• Principal investigator: Lin Shen, MD — Department of Medical Oncology, Beijing
• Study coordinator: Li Wei, Md

Conditions Gastroesophageal Junction Adenocarcinoma; Neoplasms