Clinical trial · Interventional
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
NCT07071714CI-TRIAL-00121545active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adebrelimab Injection | Drug | Adebrelimab | ALIAS |
| Bevacizumab Injection | Drug | Bevacizumab | ALIAS |
| SHR-8068 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A Group
- interventionNames
- Drug: SHR-8068 Injection
- Drug: Adebrelimab Injection
- type
- EXPERIMENTAL
- label
- Part B Group
- interventionNames
- Drug: SHR-8068 Injection
- Drug: Adebrelimab Injection
- Drug: Bevacizumab Injection
Primary outcomes (2)
- measure
- Pathological Complete Response (pCR)
- timeFrame
- About 7 months.
- measure
- Progression Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.