SHR-8068 combined with adebrelimab and bevacizumab for colorectal cancer

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

This trial will try SHR-8068 together with other cancer medicines in adults with colorectal cancer to see if the combination is safe and helps control the disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07071714 on ClinicalTrials.gov

What this trial studies

This Phase II trial gives SHR-8068 in combination with anti-tumor therapies (including adebrelimab and bevacizumab) to adults with colorectal cancer to study safety, tolerability, and preliminary efficacy. Eligible participants are 18–75 years old with ECOG performance status 0–1 and must provide tumor tissue for genetic testing; the trial includes parts with different life-expectancy requirements. Key exclusions include active untreated CNS metastases, known interstitial pneumonia, uncontrolled symptomatic ascites or pleural effusion, and recent systemic antitumor therapy. The single-site trial is sponsored by Suzhou Suncadia Biopharmaceuticals and conducted at The Sixth Affiliated Hospital of Sun Yat-sen University in Guangzhou.

Who should consider this trial

Good fit: Adults aged 18–75 with colorectal cancer, ECOG 0–1, able to provide tumor tissue samples, and meeting the study's life-expectancy and safety criteria are the ideal candidates.

Not a fit: Patients with active or untreated brain metastases, known or suspected interstitial pneumonia, uncontrolled symptomatic ascites or pleural effusion, recent systemic therapy, or poor performance status are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this combination could provide a new treatment option that better controls tumor growth and prolongs benefit for some patients with colorectal cancer.

How similar studies have performed: Combining immune checkpoint agents and anti-VEGF therapy has shown benefit in select colorectal cancer subgroups (particularly MSI-high), but combining a novel agent like SHR-8068 is a relatively new approach with limited prior data.

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.

Where this trial is running

Guangzhou, Guangdong

• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Chuanpei Huang

Conditions Colorectal Cancer