Status:
UNKNOWN
The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors
Lead Sponsor:
QureBio Ltd.
Conditions:
Gastroesophageal Junction (GEJ) Adenocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 30 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05964543
Start Date
June 21 2023
End Date
August 30 2025
Last Update
July 28 2023
Active Locations (1)
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1
Beijing cancer hospical
Beijing, Beijing Municipality, China, 100142