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
1 other identifier
interventional
130
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 10, 2024
CompletedStudy Start
First participant enrolled
September 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
ExpectedSeptember 19, 2024
September 1, 2024
9 months
June 25, 2024
September 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
ORR
Objective response rate
12 months
Safety and tolerability
Safety and tolerability assessed by incidence and severity of adverse events
12 months
Secondary Outcomes (1)
PFS
24 months
Study Arms (7)
SSGJ-707(dose 1)+ XELOX
EXPERIMENTALSSGJ-707(dose 1)+ mFOLFOX6
EXPERIMENTALSSGJ-707(dose 2)+ XELOX
EXPERIMENTALSSGJ-707(dose 2)+ mFOLFOX6
EXPERIMENTALSSGJ-707+XELOX/mFOLFOX6
EXPERIMENTALBevacizumab+XELOX/mFOLFOX6
ACTIVE COMPARATORSSGJ-707 monotherapy
EXPERIMENTALInterventions
bispecific antibody
chemotherapy
chemotherapy
chemotherapy
chemotherapy
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Liu Tianshu
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 25, 2024
First Posted
July 10, 2024
Study Start
September 3, 2024
Primary Completion
June 1, 2025
Study Completion (Estimated)
June 1, 2027
Last Updated
September 19, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will not share