Clinical trial NCT05838066: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Lead sponsor: Shanghai JMT-Bio Inc.
Sponsor class: INDUSTRY
First posted: 2023-05-01
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: The purpose of this study is to assess the efficacy and safety of KN026 combined with HB1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer. This study will establish an independent data monitoring committee (IDMC) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. During the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. In addition, the IDMC plans to conduct one interim analysis of efficacy during the study period.

The primary study hypotheses are that the combination of KN026 combined with HB1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: Progression-free Survival (PFS) as assessed by the BIRC per Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Eligibility criteria: 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.

Primary outcomes:
measure: Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1).
timeFrame: Up to approximately 4 years
Secondary outcomes:
measure: PFS (investigator assessment, RECIST1.1)
timeFrame: Up to approximately 4 years
measure: Overall survival (OS)
timeFrame: Up to approximately 4 years
measure: Objective response rate (ORR)
timeFrame: Up to approximately 4 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 4 years
measure: Duration of response (DoR)
timeFrame: Up to approximately 4 years
measure: Frequency and severity of TEAE and SAE
timeFrame: Up to approximately 4 years
measure: Concentration of KN026 in serum
timeFrame: Up to approximately 4 years
measure: Concentration of HB1801 in serum
timeFrame: Up to approximately 4 years
measure: Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable)
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Clinical Trials Information Group
state: chaoyang
Study officials:
References: