RecruitingPhase 2NCT07071714

A Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer

An Open, Multicenter Phase II Study of SHR-8068 Injection in Combination With Anti-tumor Therapies in Colorectal Cancer

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

200 participants

Start Date

Jul 22, 2025

Study Type

INTERVENTIONAL

Conditions

Colorectal, Cancer

Summary

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-8068 injection in combination with anti-tumor therapies in subjects with colorectal cancer.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
Male or female ≥ 18 years old and ≤75 years old.
ECOG performance status of 0-1.
Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks.
Need to provided tumor tissue samples for genetic testing.

Exclusion Criteria10

Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
Part B: Systemic antitumor therapy was received 4 weeks before the start of the study.
Part B: Palliative radiotherapy was completed within 14 days before the first dose.
Subjects with known or suspected interstitial pneumonia.
Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
Have poorly controlled or severe cardiovascular disease.
Subjects with active hepatitis B or active hepatitis C.
A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention.
Any other factors that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate as judged by investigators.