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ACTIVE_NOT_RECRUITINGPHASE3

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

NCT06199973•Suzhou Suncadia Biopharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

The study is being conducted to evaluate the efficacy, and safety of SHR-A1811 in advanced colorectal cancer subjects.

Eligibility

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

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;
•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.

Locations (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

March 1, 2024

Primary Completion Date

April 1, 2026

Completion Date

June 1, 2026

Last Updated

July 17, 2025

Enrollment

130

ACTUAL participants

Conditions

Advanced Colorectal Cancer

Interventions

SHR-A1811

DRUG

TAS-102, Regorafenib , Fruquintinib

DRUG

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

NCT07321106

Colorectal CancerColorectal Cancer (CRC)+5 more

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RECRUITINGPHASE2

Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer

NCT06824064

Metastatic Colorectal CancerAdvanced Colorectal Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer

Evaluation of RBS2418 in Patients With Advanced, Metastatic, and Progressive Colorectal Cancer

Efficacy of Tunlametinib in Combination With Anti-EGFR Monoclonal Antibody in Patients With RAS-Mutated Advanced Gastrointestinal Malignancies

Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Advanced Colon Cancer

Assessment of the Dose Safety and Efficacy of Serine Combined With Fluorouracil Drugs

Fruquintinib Combined With Chemotherapy as Third-line /Third-line+ Treatment in Advanced Colorectal Cancer