> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-kn026-in-combination-with-hb1801-in-18ecbf53-6780-47c4-8cc7-c98113a5466a > Record changed: 2026-11-04 # Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer. NCT05838066 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) Participants 880 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) Lead sponsor Shanghai JMT-Bio Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) Start date 2023-07-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Title and summary **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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Dates **Completion date** 2027-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **First posted** 2023-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Registry last updated** 2025-05-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Primary completion date** 2025-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Start date** 2023-07-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Size and sites **Participants** 880 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Planned participants** 880 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Lead sponsor** Shanghai JMT-Bio Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Identifiers **Registry ID** NCT05838066 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **ClinicalTrials.gov ID** NCT05838066 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Outcomes ### Primary outcomes 1. Free-progression survival (PFS) as evaluated by BIRC (RECIST1.1). Timeframe: Up to approximately 4 years ### Secondary outcomes 1. PFS (investigator assessment, RECIST1.1) Timeframe: Up to approximately 4 years 2. Overall survival (OS) Timeframe: Up to approximately 4 years 3. Objective response rate (ORR) Timeframe: Up to approximately 4 years 4. Disease control rate (DCR) Timeframe: Up to approximately 4 years 5. Duration of response (DoR) Timeframe: Up to approximately 4 years 6. Frequency and severity of TEAE and SAE Timeframe: Up to approximately 4 years 7. Concentration of KN026 in serum Timeframe: Up to approximately 4 years 8. Concentration of HB1801 in serum Timeframe: Up to approximately 4 years 9. Incidence of KN026 Anti-drug antibody (ADA) and neutralizing antibody (Nab) (if applicable) Timeframe: Up to approximately 4 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Eligibility **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Sites - Clinical Trials Information GroupBeijing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05838066) ## Related records ### Drugs (3) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Pertuzumab](https://trialight.com/data/asset/pertuzumab-7def4e95-509d-4b35-aeb9-a153ec48056d.md) - [Trastuzumab](https://trialight.com/data/asset/trastuzumab-0f66b952-86b3-4152-b427-158320504c8a.md) ### Lead sponsors (1) - [Shanghai JMT-Bio Inc.](https://trialight.com/data/company/shanghai-jmt-bio-inc-b2cc36d1-7731-4e40-acac-4f4564462800.md) ### Conditions (1) - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) Primary condition ### Targets (17) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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