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

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.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Bevacizumab Injection; Drug: SHR-8068 Injection; Drug: Adebrelimab Injection

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Chuanpei Huang; Phone Number: +86-021-61053363; Email: chuanpei.huang@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510655
      • Recruiting
      • The sixth affiliated hospital of Sun Yat-Sen University
      • Principal Investigator: Yanhong Deng
      • Principal Investigator: Xiaojian Wu
      • Contact: Xiaojian Wu; Phone Number: +86-020-38254000; Email: 13760608396@163.com
      • Contact: Yanhong Deng; Phone Number: +86-020-38379762; Email: 13925106525@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A Group	Drug: SHR-8068 Injection; SHR-8068 injection.; Drug: Adebrelimab Injection; Adebrelimab injection.
Experimental: Part B Group	Drug: Bevacizumab Injection; Bevacizumab injection.; Drug: SHR-8068 Injection; SHR-8068 injection.; Drug: Adebrelimab Injection; Adebrelimab injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological Complete Response (pCR)	About 7 months.
Progression Free Survival (PFS)	About 18 months.

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Complete Response (cCR)	About 60 months.
Disease Free Survival (DFS)	About 60 months.
Event Free Survival (EFS）	About 60 months.
Overall Survival (OS)	About 60 months.
Duration of Response (DoR)	About 18 months.
Overall Response Rate (ORR)	About 18 months.
Disease Control Rate (DCR)	About 18 months.
Adverse Events (AEs)	Up to about 18 months.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): July 22, 2025
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031

Study Registration Dates

• First Submitted: July 8, 2025
• First Submitted That Met QC Criteria: July 8, 2025
• First Posted (Actual): July 17, 2025

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab
• Other Study ID Numbers: SHR-8068-206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No