NCT07071714Active, not recruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 103 (actual)
- First submitted
- 8 Jul 2025
- Start date
- 22 Jul 2025
- Primary completion date
- Oct 2031
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Diseases
- Colorectal cancer
- NCT number
- NCT07071714
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 103
- From 22 Jul 2025 to the primary completion date, Oct 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- Toxicity and/or complications from previous interventions did not return to NCI-CTCAE level ≤1 or exclusion criteria.
Other illness
- Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
- 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.
Other
- Subjects with known or suspected interstitial pneumonia.
- Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.