Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
- Summary
- This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with HER2-positive recurrent or metastatic breast cancer. The statistical assumption for this study is superiority. The primary study endpoint was PFS as assessed by Blinded Independ Review Committee (BIRC).
- Short title
- Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
- Official title
- A Randomized, Controlled, Open-label, Multicenter, Phase Ш Clinical Study of the Efficacy and Safety of KN026 in Combination With HB1801 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2027-12-31
- First posted
- 2023-05-01
- Registry last updated
- 2025-05-30
- Primary completion date
- 2025-07-31
- Start date
- 2023-07-23
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05838066
- ClinicalTrials.gov ID
- NCT05838066
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1).
Timeframe: Up to approximately 4 years
PFS (investigator assessment, RECIST1.1)
Timeframe: Up to approximately 4 years
Overall survival (OS)
Timeframe: Up to approximately 4 years
Objective response rate (ORR)
Timeframe: Up to approximately 4 years
Disease control rate (DCR)
Timeframe: Up to approximately 4 years
Duration of response (DoR)
Timeframe: Up to approximately 4 years
Frequency and severity of TEAE and SAE
Timeframe: Up to approximately 4 years
Concentration of KN026 in serum
Timeframe: Up to approximately 4 years
Concentration of HB1801 in serum
Timeframe: Up to approximately 4 years
Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)
Timeframe: Up to approximately 4 years
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
Key Inclusion Criteria:
- Voluntarily enrolled in this study and signed an informed consent form (ICF).
- Age ≥ 18 years.
- Recurrent or metastatic breast cancer confirmed by histology and/or cytology.
- Latest tumor tissue sample confirmed as HER2 positive by central laboratory testing.
- No prior systemic chemotherapy and/or HER2-targeted therapy for recurrent or metastatic breast cancer.
- Eastern Cooperative Oncology Group (ECOG) physical status score of 0 - 1.
- Presence of lesion (RECIST 1.1).
- Adequate organ and bone marrow function
Key Exclusion Criteria:
- Ineligible for any of the agents on the study
- Untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis.
- Pregnant or lactating women.
- Presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
- Clinical Trials Information GroupBeijing, ChinaRecruiting
Related records
Drugs (3)
Lead sponsors (1)
Conditions (1)
- Breast neoplasm Primary condition