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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07071714
Enrollment
200
Registered
2025-07-17
Start date
2025-07-22
Completion date
2031-10-01
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DRUGSHR-8068 Injection

SHR-8068 injection.

DRUGAdebrelimab Injection

Adebrelimab injection.

DRUGBevacizumab Injection

Bevacizumab injection.

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pathological Complete Response (pCR)About 7 months.
Progression Free Survival (PFS)About 18 months.

Secondary

MeasureTime 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.

Countries

China

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026