Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07071714

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

Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-03-18

200

Participants Needed

1

Research Sites

323 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
  • Male or female aged 18 to 75 years old.
  • ECOG performance status of 0-1.
  • Part A participants must have a life expectancy of 2 years or more; Part B participants must have a life expectancy of at least 12 weeks.
  • Must provide tumor tissue samples for genetic testing.
Not Eligible

You will not qualify if you...

  • For Part B: untreated or active central nervous system metastases or history of meningeal metastasis.
  • For Part B: systemic antitumor therapy received within 4 weeks before study start.
  • For Part B: palliative radiotherapy completed within 14 days before first dose.
  • Toxicity or complications from previous treatments not recovered to mild levels (NCI-CTCAE level 1 or better).
  • Known or suspected interstitial pneumonia.
  • Moderate or severe ascites with symptoms; uncontrolled or moderate/higher pleural or pericardial effusion.
  • Poorly controlled or severe cardiovascular disease.
  • Active hepatitis B or hepatitis C infection.
  • History of immunodeficiency including positive HIV test or organ transplantation.
  • Uncontrolled mental illness or conditions affecting study completion such as substance abuse or criminal detention.
  • Any other factors increasing risk, interfering with results, or judged inappropriate by investigators.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China, 510655

Actively Recruiting

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Research Team

C

Chuanpei Huang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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