A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients
NCT ID: NCT06493760
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
130 participants
INTERVENTIONAL
2024-09-03
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SSGJ-707(dose 1)+ XELOX
SSGJ-707
bispecific antibody
Oxaliplatin
chemotherapy
Capecitabine
chemotherapy
SSGJ-707(dose 1)+ mFOLFOX6
SSGJ-707
bispecific antibody
Oxaliplatin
chemotherapy
Calcium Folinate
chemotherapy
5-fluorouracil
chemotherapy
SSGJ-707(dose 2)+ XELOX
SSGJ-707
bispecific antibody
Oxaliplatin
chemotherapy
Capecitabine
chemotherapy
SSGJ-707(dose 2)+ mFOLFOX6
SSGJ-707
bispecific antibody
Oxaliplatin
chemotherapy
Calcium Folinate
chemotherapy
5-fluorouracil
chemotherapy
SSGJ-707+XELOX/mFOLFOX6
SSGJ-707
bispecific antibody
Oxaliplatin
chemotherapy
Capecitabine
chemotherapy
Calcium Folinate
chemotherapy
5-fluorouracil
chemotherapy
Bevacizumab+XELOX/mFOLFOX6
Bevacizumab
VEGF antibody
Oxaliplatin
chemotherapy
Capecitabine
chemotherapy
Calcium Folinate
chemotherapy
5-fluorouracil
chemotherapy
SSGJ-707 monotherapy
SSGJ-707
bispecific antibody
Interventions
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SSGJ-707
bispecific antibody
Bevacizumab
VEGF antibody
Oxaliplatin
chemotherapy
Capecitabine
chemotherapy
Calcium Folinate
chemotherapy
5-fluorouracil
chemotherapy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Liu Tianshu
Shanghai, Shanghai Municipality, China
Countries
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Facility Contacts
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Liu Tianshu, PhD
Role: backup
Other Identifiers
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SSGJ-707-CRC-II-01
Identifier Type: -
Identifier Source: org_study_id
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