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Trial Title:
The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors
NCT ID:
NCT05964543
Condition:
Gastroesophageal Junction (GEJ) Adenocarcinoma
Conditions: Official terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Capecitabine
Oxaliplatin
Conditions: Keywords:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Phase Ib: Dose escalation;Phase II:Arm A：Combined administration group Q-1802 plus
XELOX,Arm B Standard treatment group: XELOX alone
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Q-1802 Injection,Oxaliplatin Injection,Capecitabine
Description:
Q-1802：A dose Q-1802 will be administered intravenously Q2W.
XELOX（oxaliplatin，capecitabin）: 21 days as a cycle Oxaliplatin will be administered
130mg/m2 as a 2-hour IV infusion,administer once on the first day, with 21 days as a
cycle Capecitabine will be administered 1000mg/m2 orally twice daily (D1-D14),21ds is one
cycle.
Arm group label:
Phase II: Q-1802 + XELOX Vs XELOX ;
Arm group label:
Phase Ib: Dose escalation Q-1802+XELOX,
Other name:
Q-1802,Oxaliplatin Injection,Xeloda
Summary:
The main purpose of this study is to evaluate safety, tolerability and the efficacy of
Q-1802 plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of
Q-1802 and the immunogenicity profile of Q-1802 will be evaluated as well.
Detailed description:
This study is a multicenter, open label, phase Ⅰb/Ⅱ clinical study conducted in
unresectable patients with advanced or recurrent metastatic Claudin18.2 positive (medium
and high expression) and HER-2 negative primary gastric adenocarcinoma or gastric
esophageal junction adenocarcinoma. The Phase Ib dose escalation study included two dose
groups each combined with the XELOX standard treatment regimen. Perform dose escalation
to obtain MTD and/or RP2D doses for combined administration. The Phase II study adopted
an open label parallel randomized controlled design. Further observe the efficacy and
safety of Q-1802 combined with XELOX regimen in treating patients with moderate to high
expression of Claudin 18.2, and compare and analyze the efficacy and safety of Q-1802
combined with XELOX regimen and XELOX regimen alone.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing cancer hospical
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Shen, MD
Phone:
86-13911219511
Email:
shenlin@bjmu.edu.cn
Start date:
June 21, 2023
Completion date:
August 30, 2025
Lead sponsor:
Agency:
QureBio Ltd.
Agency class:
Industry
Source:
QureBio Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05964543
