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

RECRUITINGPhase 2Sponsored by Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Actively Recruiting
PhasePhase 2
SponsorSunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Started2024-09-03
Est. completion2025-06
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
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.

Conditions2

CancerMetastatic Colorectal Cancer

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