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

Launched by SUZHOU SUNCADIA BIOPHARMACEUTICALS CO., LTD. · Jul 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SHR-8068, given as an injection alongside other cancer-fighting therapies, to see if it is safe and effective for people with colorectal cancer. The goal is to understand how well this combination works and how well patients tolerate it. Right now, the study is not yet recruiting participants.

Adults between 18 and 75 years old with colorectal cancer may be eligible to join if they are generally in good health and able to carry out daily activities (this is measured by a standard scale called ECOG 0-1). Participants will need to agree to provide tumor tissue samples for genetic testing, which helps doctors understand the cancer better. Those who join can expect careful monitoring for side effects and regular check-ups during the study. Some people won’t be able to join, such as those with certain brain metastases, recent cancer treatments, serious infections like active hepatitis or HIV, or uncontrolled health problems. It’s important for participants to be able to complete the study safely and follow all study procedures.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
• • 2. Male or female ≥ 18 years old and ≤75 years old.
• • 3. ECOG performance status of 0-1.
• • 4. Part A with a life expectancy of ≥2 years. Part B with a life expectancy of ≥12 weeks.
• • 5. Need to provided tumor tissue samples for genetic testing.
• Exclusion Criteria:
• • 1. Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
• • 2. Part B: Systemic antitumor therapy was received 4 weeks before the start of the study.
• • 3. Part B: Palliative radiotherapy was completed within 14 days before the first dose.
• • 4. Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria.
• • 5. Subjects with known or suspected interstitial pneumonia.
• • 6. Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
• • 7. Have poorly controlled or severe cardiovascular disease.
• • 8. Subjects with active hepatitis B or active hepatitis C.
• • 9. A history of immunodeficiency, including a positive HIV test, other acquired or congenital immunodeficiency disorders, or a history of organ transplantation.
• • 10. 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.
• • 11. 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.