RecruitingPhase 2NCT06493760
A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients
A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients
Sponsor
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Enrollment
130 participants
Start Date
Sep 3, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria5
- Males and/or females over age 18
- Histologically and/or cytologically documented metastatic colorectal cancer confirmed .
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Expected survival \>=12 weeks.
- Signed informed consent form.
Exclusion Criteria5
- Known uncontrolled or symptomatic central nervous system metastatic disease.
- 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).
- Inadequate organ or bone marrow function.
- Pregnant or breast-feeding woman.
- 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.
Interventions
DRUGSSGJ-707
bispecific antibody
DRUGBevacizumab
VEGF antibody
DRUGOxaliplatin
chemotherapy
DRUGCapecitabine
chemotherapy
DRUGCalcium Folinate
chemotherapy
DRUG5-fluorouracil
chemotherapy
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06493760
Related Trials
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
NCT0465706879 locations
Open-label Phase 1b Study of Ulixertinib and Cetuximab or Ulixertinib in Combination With Cetuximab and Encorafenib in Patients With Unresectable or Metastatic Colorectal Cancer Who Have Previously Received EGFR or BRAF-directed Therapy
NCT059859541 location
A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid/Leucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer
NCT0682046341 locations
Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)
NCT061494811 location
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer
NCT0707963113 locations