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Trial Title:
A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients
NCT ID:
NCT06493760
Condition:
Metastatic Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Leucovorin
Bevacizumab
Capecitabine
Oxaliplatin
Fluorouracil
Calcium
Levoleucovorin
Conditions: Keywords:
SSGJ-707
colorectal cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SSGJ-707
Description:
bispecific antibody
Arm group label:
SSGJ-707 monotherapy
Arm group label:
SSGJ-707(dose 1)+ XELOX
Arm group label:
SSGJ-707(dose 1)+ mFOLFOX6
Arm group label:
SSGJ-707(dose 2)+ XELOX
Arm group label:
SSGJ-707(dose 2)+ mFOLFOX6
Arm group label:
SSGJ-707+XELOX/mFOLFOX6
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
VEGF antibody
Arm group label:
Bevacizumab+XELOX/mFOLFOX6
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
chemotherapy
Arm group label:
Bevacizumab+XELOX/mFOLFOX6
Arm group label:
SSGJ-707(dose 1)+ XELOX
Arm group label:
SSGJ-707(dose 1)+ mFOLFOX6
Arm group label:
SSGJ-707(dose 2)+ XELOX
Arm group label:
SSGJ-707(dose 2)+ mFOLFOX6
Arm group label:
SSGJ-707+XELOX/mFOLFOX6
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
chemotherapy
Arm group label:
Bevacizumab+XELOX/mFOLFOX6
Arm group label:
SSGJ-707(dose 1)+ XELOX
Arm group label:
SSGJ-707(dose 2)+ XELOX
Arm group label:
SSGJ-707+XELOX/mFOLFOX6
Intervention type:
Drug
Intervention name:
Calcium Folinate
Description:
chemotherapy
Arm group label:
Bevacizumab+XELOX/mFOLFOX6
Arm group label:
SSGJ-707(dose 1)+ mFOLFOX6
Arm group label:
SSGJ-707(dose 2)+ mFOLFOX6
Arm group label:
SSGJ-707+XELOX/mFOLFOX6
Intervention type:
Drug
Intervention name:
5-fluorouracil
Description:
chemotherapy
Arm group label:
Bevacizumab+XELOX/mFOLFOX6
Arm group label:
SSGJ-707(dose 1)+ mFOLFOX6
Arm group label:
SSGJ-707(dose 2)+ mFOLFOX6
Arm group label:
SSGJ-707+XELOX/mFOLFOX6
Summary:
This study includes two parts:Part 1: SSGJ-707 (different dosing regimens) in combination
with chemotherapy for first-line treatment of metastatic colorectal cancer.Part 2:
SSGJ-707 in combination with chemotherapy versus bevacizumab in combination with
chemotherapy for first-line treatment of metastatic colorectal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Males and/or females over age 18
2. Histologically and/or cytologically documented metastatic colorectal cancer
confirmed .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival >=12 weeks.
5. Signed informed consent form.
Exclusion Criteria:
1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer
therapy of grade >1 (National Cancer Institute Common terminology Criteria [NCI
CTCAE] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information
was not intended to contain all considerations relevant to a participant's potential
participation in a clinical trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Liu Tianshu
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Liu Tianshu, PhD
Phone:
13681973996
Email:
liu.tianshu@zs-hospital.sh.cn
Contact backup:
Last name:
Liu Tianshu, PhD
Start date:
September 3, 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Agency class:
Industry
Source:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06493760
