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

NCT ID: NCT07071714

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-22

Study Completion Date

2031-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A Group

Group Type EXPERIMENTAL

SHR-8068 Injection

Intervention Type DRUG

SHR-8068 injection.

Adebrelimab Injection

Intervention Type DRUG

Adebrelimab injection.

Part B Group

Group Type EXPERIMENTAL

SHR-8068 Injection

Intervention Type DRUG

SHR-8068 injection.

Adebrelimab Injection

Intervention Type DRUG

Adebrelimab injection.

Bevacizumab Injection

Intervention Type DRUG

Bevacizumab injection.

Interventions

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SHR-8068 Injection

SHR-8068 injection.

Intervention Type DRUG

Adebrelimab Injection

Adebrelimab injection.

Intervention Type DRUG

Bevacizumab Injection

Bevacizumab injection.

Intervention Type DRUG

Eligibility Criteria

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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.
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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chuanpei Huang

Role: CONTACT

+86-021-61053363

Facility Contacts

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Xiaojian Wu

Role: primary

+86-020-38254000

Yanhong Deng

Role: backup

+86-020-38379762

Other Identifiers

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SHR-8068-206

Identifier Type: -

Identifier Source: org_study_id

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