NCT07071714

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2 colorectal-cancer

Timeline
65mo left

Started Jul 2025

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Jul 2025Oct 2031

First Submitted

Initial submission to the registry

July 8, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 17, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

July 22, 2025

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2031

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

6.2 years

First QC Date

July 8, 2025

Last Update Submit

March 16, 2026

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Pathological Complete Response (pCR)

    About 7 months.

  • Progression Free Survival (PFS)

    About 18 months.

Secondary Outcomes (8)

  • 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.

  • +3 more secondary outcomes

Study Arms (2)

Part A Group

EXPERIMENTAL
Drug: SHR-8068 InjectionDrug: Adebrelimab Injection

Part B Group

EXPERIMENTAL
Drug: SHR-8068 InjectionDrug: Adebrelimab InjectionDrug: Bevacizumab Injection

Interventions

SHR-8068 InjectionDRUG

SHR-8068 injection.

Part A GroupPart B Group
Adebrelimab InjectionDRUG

Adebrelimab injection.

Part A GroupPart B Group
Bevacizumab InjectionDRUG

Bevacizumab injection.

Part B Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Part B: Accompanied by untreated or active central nervous system (CNS) metastases. Subjects with a history or current history of meningeal metastasis.
  • 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.
  • Subjects with known or suspected interstitial pneumonia.
  • Moderate or severe ascites with clinical symptoms; Uncontrolled or moderate or higher pleural effusion or pericardial effusion.
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Chuanpei Huang

CONTACT

+86-021-61053363chuanpei.huang@hengrui.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2025

First Posted

July 17, 2025

Study Start

July 22, 2025

Primary Completion (Estimated)

October 1, 2031

Study Completion (Estimated)

October 1, 2031

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

CN(1)