A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients

Phase 2

Not yet recruiting

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: Bevacizumab; Drug: SSGJ-707; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Calcium Folinate; Drug: 5-fluorouracil

• Registration Number: NCT06493760
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-07-09
• Study First Posted: 2024-07-10
• Status Verified: 2024-08
• Study Start: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab+XELOX/mFOLFOX6	Bevacizumab	-
SSGJ-707+XELOX/mFOLFOX6	SSGJ-707	-
SSGJ-707+XELOX/mFOLFOX6	Calcium Folinate	-
SSGJ-707 monotherapy	SSGJ-707	-
SSGJ-707(dose 1)+ XELOX	SSGJ-707	-
SSGJ-707(dose 1)+ mFOLFOX6	SSGJ-707	-
SSGJ-707(dose 1)+ mFOLFOX6	Calcium Folinate	-
SSGJ-707(dose 2)+ XELOX	SSGJ-707	-
SSGJ-707(dose 2)+ mFOLFOX6	Calcium Folinate	-
SSGJ-707(dose 2)+ mFOLFOX6	5-fluorouracil	-
SSGJ-707+XELOX/mFOLFOX6	Capecitabine	-
Bevacizumab+XELOX/mFOLFOX6	Oxaliplatin	-
SSGJ-707(dose 2)+ mFOLFOX6	Oxaliplatin	-
SSGJ-707+XELOX/mFOLFOX6	5-fluorouracil	-
Bevacizumab+XELOX/mFOLFOX6	5-fluorouracil	-
Bevacizumab+XELOX/mFOLFOX6	Capecitabine	-
Bevacizumab+XELOX/mFOLFOX6	Calcium Folinate	-
SSGJ-707(dose 2)+ mFOLFOX6	SSGJ-707	-
SSGJ-707(dose 1)+ XELOX	Oxaliplatin	-
SSGJ-707(dose 1)+ XELOX	Capecitabine	-
SSGJ-707(dose 1)+ mFOLFOX6	Oxaliplatin	-
SSGJ-707(dose 1)+ mFOLFOX6	5-fluorouracil	-
SSGJ-707(dose 2)+ XELOX	Oxaliplatin	-
SSGJ-707(dose 2)+ XELOX	Capecitabine	-
SSGJ-707+XELOX/mFOLFOX6	Oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
ORR	12 months	Objective response rate
Safety and tolerability	12 months	Safety and tolerability assessed by incidence and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
PFS	24 months	The efficacy end points

Trial Locations

Locations (1)

Liu Tianshu; 🇨🇳 Shanghai, Shanghai, China