- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05964543
The Safety and Efficacy of Q-1802 Combined With XELOX in 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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: LI WEI, MD
- Phone Number: 86-021-50920280
- Email: weili@qurebio.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing cancer hospical
-
Contact:
- Lin Shen, MD
- Phone Number: 86-13911219511
- Email: shenlin@bjmu.edu.cn
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Phase Ib: Dose escalation Q-1802+XELOX,
According to "3+3" design, a dose of Q-1802 with two dose groups from low to high and one cycle fixed-dose XELOX will be given in DLT observation period.
After DLT observation period, Q-1802+XELOX will be given by investigator,s decision until the subject meets study treatment discontinuation criteria.
|
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.
Other Names:
|
Placebo Comparator: Phase II: Q-1802 + XELOX Vs XELOX ;
Phase II:Participants will be randomized to group A and B. Group A:receive a dose of Q-1802 at Cycle 1 Day 1 followed by a same dose in subsequent cycles every 2 weeks.
Additionally, participants will receive XELOX (capecitabine/oxaliplatin) treatment until investigator confirmed disease progression or a total of 8 treatments (each cycle is defined as approximately 21 days).
Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14.
After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive Q-1802 a every 2 weeks each cycle and capecitabine every 3 weeks at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Group B:Participants will receive XELOX (capecitabine/oxaliplatin) treatment alone until a total of 8 treatments (each cycle is defined as approximately 21 days).
subjects may continue to receive capecitabine every 3 weeks at the investigator's discretion.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with treatment-related adverse events(TRAE)
Time Frame: From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months
|
TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802
|
From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months
|
Objective response rate (ORR)
Time Frame: From the first dose of study drug administration up to 6 months after the last pts in,up to19 months
|
ORR is defined as proportion of participants with complete response, partial response (CR+PR).
|
From the first dose of study drug administration up to 6 months after the last pts in,up to19 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: From the first dose of study drug administration up to the last pts who disease progression or death which occurs first,up to 21months
|
PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.
|
From the first dose of study drug administration up to the last pts who disease progression or death which occurs first,up to 21months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lin Shen, MD, Department of Medical Oncology, Beijing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Q-1802-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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