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Recruiting Phase 2 NCT06493760

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

Trial Parameters

Condition Metastatic Colorectal Cancer
Sponsor Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 130
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2024-09-03
Completion 2025-06
Interventions
SSGJ-707BevacizumabOxaliplatin

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.

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.

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