A Randomized, Open-Label, Controlled, Multicenter Phase III Clinical Study of SHR-A1811 in Combination With Chemotherapy and Bevacizumab Versus Standard Therapy as First-Line Treatment for Advanced Colorectal Cancer

NCT07676162 | Not Yet Recruiting Phase 3

• 1 other identifier: SHR-A1811-317
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study adopts a randomized, open-label, positive-controlled, multicenter design, aiming to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and bevacizumab versus standard therapy as first-line treatment for advanced colorectal cancer, and to explore the drug's immunogenicity and pharmacokinetic characteristics.

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) assessed by the Independent Review Committee (IRC)

  From the first dose to the last visit, approximately11 months

Secondary Outcomes (9)

• Objective Response Rate (ORR) assessed by Independent Review Committee (IRC)

  From the first dose to the last visit, approximately 11months

• Duration of Response (DoR) assessed by Independent Review Committee (IRC)

  From the first dose to the last visit, approximately 11months

• Progression-Free Survival (PFS) assessed by the Investigator

  From the first dose to the last visit, approximately11 months

• Objective Response Rate (ORR) assessed by the Investigator

  From the first dose to the last visit, approximately 11 months

• Duration of Response (DoR) assessed by the Investigator

  From the first dose to the last visit, approximately 11 months

Study Arms (2)

Treatment group A

EXPERIMENTAL

SHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

Drug: SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

Treatment group B

ACTIVE COMPARATOR

Standard First-line treatment

Drug: Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

Interventions

SHR-A1811, Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab DRUG

SHR-A1811 in combination with Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

Treatment group A

Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab DRUG

Oxaliplatin, Levo-leucovorin, Fluorouracil and Bevacizumab

Treatment group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects voluntarily enroll in the study, sign informed consent, demonstrate good compliance and cooperate with follow-up visits.
• Aged between 18 and 75 years inclusive, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Estimated survival expectancy ≥ 12 weeks.
• Histologically or cytologically confirmed colorectal adenocarcinoma.
• No prior systemic anti-tumor therapy.
• Tumor tissue specimen must be provided, either archived within 1 year prior to first study treatment or newly collected fresh specimen.
• At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; the measurable lesion shall not have received prior local therapy such as radiotherapy.
• Adequate organ function with relevant laboratory tests completed within 7 days before the first study treatment.
• Male subjects with fertile female partners and fertile female subjects must use highly effective contraception throughout the study. Fertile female subjects must have a negative serum or urine human chorionic gonadotropin (HCG) test within 7 days prior to first study drug administration and shall not be breastfeeding.

You may not qualify if:

• Received systemic anti-tumor therapies (including investigational agents) or major surgery within 4 weeks prior to the first study drug administration; palliative radiotherapy within 2 weeks or surgery within 4 weeks before study treatment initiation.
• History of hypersensitivity to monoclonal antibodies or any component of the investigational products to be administered in this study.
• Pre-existing peripheral neuropathy of Grade \>1.
• History of thromboembolic disease within 6 months or hemoptysis within 3 months before first study medication. Subjects with muscular venous thrombosis not requiring anticoagulation per investigator's assessment are eligible for enrollment.
• CT/MRI evidence of tumor encasement or invasion of major blood vessels.
• Non-gastrointestinal bleeding within 6 months prior to first study drug administration, or active peptic ulcer disease.
• Uncontrolled hypertension, or medical history of hypertensive crisis or hypertensive encephalopathy.
• History of severe cerebrovascular disease.
• Unresolved toxicities and/or complications from prior interventions that have not recovered to baseline.
• Subjects with a history of or current leptomeningeal metastases, or active brain metastases.
• Known or suspected interstitial lung disease (ILD); moderate-to-severe pulmonary disease significantly impairing respiratory function or autoimmune/connective tissue/inflammatory diseases involving the lung within 3 months before first dosing that may interfere with detection or management of drug-related pulmonary toxicity. Subjects who developed ≥Grade 3 ILD during prior immune checkpoint inhibitor treatment are excluded.
• Symptomatic moderate to severe ascites; uncontrolled moderate or greater pleural or pericardial effusion.
• Bowel obstruction within 3 months prior to first study treatment, or prior intestinal stent placement with the stent remaining in situ at screening.
• Uncontrolled or severe cardiovascular disease, or unstable angina/unstable arrhythmia occurring within 1 month before initiation of study treatment.
• Unexplained fever \>38.5°C at screening or prior to first dose; severe infection (CTCAE Grade \>2) within 4 weeks before study drug initiation; active pulmonary inflammation on baseline chest imaging, or clinical signs/symptoms of infection requiring oral or intravenous antibiotics within 2 weeks before first dosing.

Sponsors & Collaborators

• Suzhou Suncadia Biopharmaceuticals Co., Ltd.: lead

Study Sites (1)

Beijing cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

MeSH Terms

Interventions

Oxaliplatin; Levoleucovorin; Fluorouracil; Bevacizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Leucovorin; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Yingyi Jiang

CONTACT

0518-82342973; yingyi.jiang.yj58@hengrui.com

Zhengjin Zhang

CONTACT

0518-82342973; zhengjin.zhang.zz79@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2026
• First Posted: June 30, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

CN (1)