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The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors

Primary Purpose

Gastroesophageal Junction (GEJ) Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Q-1802 Injection,Oxaliplatin Injection,Capecitabine
Sponsored by
QureBio Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Junction (GEJ) Adenocarcinoma focused on measuring Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing cancer hospicalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phase Ib: Dose escalation Q-1802+XELOX,

Phase II: Q-1802 + XELOX Vs XELOX ;

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of participants with treatment-related adverse events(TRAE)
TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802
Objective response rate (ORR)
ORR is defined as proportion of participants with complete response, partial response (CR+PR).

Secondary Outcome Measures

Progression-free survival (PFS)
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.

Full Information

First Posted
July 19, 2023
Last Updated
July 27, 2023
Sponsor
QureBio Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05964543
Brief Title
The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
August 30, 2024 (Anticipated)
Study Completion Date
August 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
QureBio Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Junction (GEJ) Adenocarcinoma
Keywords
Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Phase Ib: Dose escalation;Phase II:Arm A：Combined administration group Q-1802 plus XELOX,Arm B Standard treatment group: XELOX alone
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase Ib: Dose escalation Q-1802+XELOX,
Arm Type
Experimental
Arm Description
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.
Arm Title
Phase II: Q-1802 + XELOX Vs XELOX ;
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Q-1802 Injection,Oxaliplatin Injection,Capecitabine
Other Intervention Name(s)
Q-1802,Oxaliplatin Injection,Xeloda
Intervention 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.
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events(TRAE)
Description
TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802
Time Frame
From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months
Title
Objective response rate (ORR)
Description
ORR is defined as proportion of participants with complete response, partial response (CR+PR).
Time Frame
From the first dose of study drug administration up to 6 months after the last pts in,up to19 months
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Description
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.
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LI WEI, MD
Phone
86-021-50920280
Email
weili@qurebio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Organizational Affiliation
Department of Medical Oncology, Beijing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing cancer hospical
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Phone
86-13911219511
Email
shenlin@bjmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors

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