Comparing SHR-A1811 to standard treatments for advanced colorectal cancer

Injection of SHR-A1811 Versus Physician Choiced Treatment in Patients With Advanced Colorectal Cancer Who Had Failed to Respond to Oxaliplatin, 5-fu, and Irinotecan

This study is testing a new treatment called SHR-A1811 to see if it works better than standard options for people with advanced colorectal cancer who haven't had success with other treatments.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 1 site (Shanghai, Shanghai)
• Trial ID: NCT06199973 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy and safety of SHR-A1811 in patients with advanced colorectal cancer who have not responded to standard treatments including oxaliplatin, 5-fluorouracil, and irinotecan. Participants will receive either SHR-A1811 or a physician-chosen treatment, with the goal of determining which option provides better outcomes. The study focuses on patients with unresectable locally advanced or metastatic colorectal cancer, ensuring that they meet specific eligibility criteria related to their disease status and overall health.

Who should consider this trial

Good fit: Ideal candidates are adults with unresectable RAS/RAF wild-type advanced colorectal cancer who have failed previous treatments.

Not a fit: Patients with resectable tumors or those who have not yet undergone standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with advanced colorectal cancer who have limited alternatives.

How similar studies have performed: Other studies have explored similar treatment approaches in advanced colorectal cancer, but the specific use of SHR-A1811 is novel.

Eligibility criteria

Inclusion Criteria:

1. Unresectable locally advanced or distant metastatic RAS/RAF wild-type colorectal cancer diagnosed histologically or cytologically;
2. After treatment with oxaliplatin, 5-fluorouracil (such as 5-FU, Capecitabine) , irinotecan (DMMR/MSI-H subjects also need anti-PD-1/PD-L1 antibody treatment failure) ;
3. According to the response evaluation criteria for solid tumors (RECIST 1.1) , having at least one measurable lesion, measurable lesions should not have received local treatment such as radiotherapy (lesions located within the previously treated area may also be targeted if progression is confirmed) .
4. ECOG physical strength score: 0-1;
5. Expected survival was ≥12 weeks;
6. 24-hour urine protein ≤1.0 g d) clotting: activated partial thromboplastin time (APTT) and international standard ratio (INR )≤1.5 × ULN (for use of a stable dose of anticoagulant therapy such as LMWH or Warfarin and INR can be screened within the expected range of anticoagulant therapy) ;
7. Eligible fertile patients (men and women) must agree to use a highly effective contraceptive method with their partner for at least 7 months during the trial and after the last dose; women of reproductive age must have a negative blood pregnancy test within 7 days before the first use of the study drug;
8. The subjects volunteered to join the study, signed the informed consent, good compliance, with follow-up.

Exclusion Criteria:

1. Subjects on systemic therapy with corticosteroid (\> 10 mg daily equivalent of prednisone) or other immunosuppressive agents, except for local inflammation and the prevention of allergy and nausea and vomiting, who had undergone major surgery or severe trauma within 4 weeks prior to the first corticosteroid of the study drug, or who required elective surgery during the trial, who had undergone minor traumatic surgery, such as needle biopsy, within 7 days prior to the first dose of the study drug;
2. Previous allergies to monoclonal antibody, formulation components of SHR-A1811 products, and fluorouracil medications;
3. Previous antineoplastic therapy toxicities did not revert to a CTCAE v5.0 grade rating of ≤1(except for toxicities that the investigator judged to have no safety risk, such as alopecia, etc.) or the level specified by the enrollment/exclusion criteria;
4. Subjects with a history of meningeal metastasis or current meningeal metastasis; active brain metastasis;
5. uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;
6. history of immunodeficiency, these included people who tested positive for HIV or who had a fever of \> 38.5 degrees of unknown cause before the first dose (cancer fever, as judged by the researchers, could be enrolled); Severe infection (CTCAE \> Grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection complications, etc. Baseline chest imaging showed active pulmonary inflammation, active hepatitis B (HBV DNA ≥500 IU/mL) and hepatitis C (HCV-RNA was higher than the lower limit of detection);
7. Other malignancies in the past 5 years, not including cured skin basal-cell carcinoma and carcinoma in situ of the cervix;
8. Pregnant or lactating women.

Where this trial is running

Shanghai, Shanghai

• Shanghai East Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Qianna Zhan

Conditions Advanced Colorectal Cancer