A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer

NCT07406542 | Not Yet Recruiting Phase 3

• 1 other identifier: SYS6010-021
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first- or second-line chemotherapy. It aims to compare the efficacy and safety of SYS6010 monotherapy versus investigator-selected chemotherapy.The study plans to enroll approximately 400 subjects, randomly assigned in a 1:1 ratio to the treatment arm and control arm(Investigator's choice of standard chemotherapy regimen, including eribulin, capecitabine, gemcitabine, or vinorelbine).

Conditions

Recurrent or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS(progression free survival) assessed by BICR based on RECIST v1.1 criteria

  Randomization up to approximately 36 months

Secondary Outcomes (11)

• OS (overall survival)

  Randomization up to approximately 60 months

• Progression-Free Survival (PFS) Assessed by Investigator

  Randomization up to approximately 36 months

• Objective Response Rate (ORR)

  Randomization up to approximately 36 months.

• Disease Control Rate (DCR)

  Randomization up to approximately 36 months.

• Duration of Response (DoR)

  Randomization up to approximately 36 months

Study Arms (2)

SYS6010

EXPERIMENTAL

Drug: SYS6010

Investigator's Choice of Chemotherapy

ACTIVE COMPARATOR

eribulin, capecitabine, gemcitabine, or vinorelbine

Drug: Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)

Interventions

SYS6010 DRUG

SYS6010, intravenous infusion

SYS6010

Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine) DRUG

eribulin 1.4 mg/m² Intravenous infusion Administered on Day 1 and Day 8, Q3W Capecitabine 1000-1250 mg/m² orally Twice daily, Days 1-14, Q3W Gemcitabine 1000 mg/m² Intravenous infusion Administered on Days 1 and 8, Q3W Vinorelbine 25 mg/m² Intravenous infusion Administered on Day 1 and Day 8, Q3W

Investigator's Choice of Chemotherapy

Eligibility Criteria

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

You may qualify if:

• Age 18 to 75 years inclusive, no gender restrictions.
• Histopathologically confirmed breast cancer at an unresectable recurrent or metastatic stage, requiring: a) HER2-negative; b) EGFR-positive expression.
• Subjects must have received 1 to 2 lines of systemic chemotherapy regimens during the unresectable advanced or metastatic stage.
• At least one measurable lesion confirmed by CT or MRI according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Brain metastases are evaluated only as non-target lesions. Patients with skin lesions only are ineligible.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
• Expected survival ≥3 months.
• Adequate major organ function status within 7 days prior to first study drug administration.
• Subjects must agree to use effective contraception from informed consent signing until the protocol-specified time after last dose; females must not be lactating and males must refrain from sperm donation during this period. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 7 days prior to the first study drug administration. Female subjects must not be lactating.
• Voluntarily participate in this clinical study, understand the research procedures, and be able to sign a written informed consent form.

You may not qualify if:

• Presence of cancerous meningitis, spinal cord compression, or active central nervous system metastases. Active central nervous system metastases are specifically defined as untreated, symptomatic, or requiring corticosteroids/anticonvulsants to control related symptoms; except for cases stable for at least one month following treatment for brain metastases and having discontinued corticosteroids/anticonvulsants for \>2 weeks.
• Poorly controlled pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention (including clinically significant recurrence requiring additional intervention within 2 weeks prior to enrollment).
• History of other malignancies within 3 years prior to first use of study drug, except for: cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, prostate carcinoma in situ, papillary thyroid carcinoma, and cervical carcinoma in situ
• Prior treatment with topoisomerase I inhibitors (including ADCs)
• Prior treatment with EGFR-targeted ADCs or monoclonal antibodies
• Known hypersensitivity to any component of SYS6010 or to humanized monoclonal antibody products
• Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 (excluding Grade 2 alopecia, asymptomatic laboratory abnormalities, etc., deemed safe by the investigator).
• Patients with inadequate washout periods for prior medications or treatments, as specified in the protocol, prior to the first administration of the study drug. 9. History of severe cardiovascular or cerebrovascular disease.
• \. Clinically significant pulmonary impairment due to pulmonary complications. 11. History of interstitial lung disease (ILD)/non-infectious pneumonia requiring glucocorticoid therapy, current ILD/non-infectious pneumonia, or inability to exclude ILD/non-infectious pneumonia based on imaging at screening.
• \. Subjects with active inflammatory bowel disease, gastrointestinal obstruction, active peptic ulcer, recent (within 4 weeks) gastrointestinal bleeding, gastrointestinal perforation, or severe gastrointestinal conditions such as abdominal abscess (excluding those with a history of resolved conditions).
• \. Severe infection within 4 weeks prior to first use of the investigational drug, including but not limited to: bacteremia requiring hospitalization, severe pneumonia, active tuberculosis infection, or requiring oral or intravenous antibiotic, antifungal, or antiviral therapy due to infection within 2 weeks prior to first dosing (except for prophylactic use).
• \. Uncontrolled diabetes (fasting blood glucose ≥10 mmol/L and/or HbA1c ≥8%). 15. Active hepatitis B, active hepatitis C virus infection, or active syphilis infection.
• \. Human immunodeficiency virus (HIV) infection diagnosed as acquired immunodeficiency syndrome (AIDS).
• Other conditions deemed unsuitable for participation in this clinical trial by the investigator (e.g., uncontrolled psychiatric disorders or anticipated poor compliance).

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

MeSH Terms

Conditions

Recurrence; Breast Neoplasms

Interventions

eribulin; Capecitabine; Gemcitabine; Vinorelbine

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

031169085587; ctr-contact@cspc.cn

Study Design

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

Model Details: multicenter, randomized, open-label, parallel-control Phase III clinical trial

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-01