Study of KN026 in Combination With Docetaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
Study Details
Study Description
Brief Summary
This is an open-lable, multicenter, and single arm phase II trial to evaluate treatment with KN026 plus docetaxel as neoadjuvant therapy in patients with early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) HER2-positive breast cancer. The subjects will receive KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles prior to surgery.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Detailed Description
KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: KN026 + Docetaxel KN026 30 mg/kg IV + Docetaxel 75/m2 every 3 weeks for four cycles |
Drug: KN026
KN026 in Combination With Docetaxel
Other Names:
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Outcome Measures
Primary Outcome Measures
- tp CR as assessed by local pathologist [up to 12 weeks]
total pathological complete response as assessed by local pathologist
Secondary Outcome Measures
- bp CR as assessed by local pathologist [up to 12 weeks]
breast pathological complete response assessed by local pathologist
- ORR as assessed by the investigator according to RECIST 1.1 [up to 12 weeks]
Objective response rate as assessed by the investigator according to RECIST 1.1
- safety as assessed by the investigator according to RECIST 1.1 [up to 12 weeks]
Incidence, type, and severity of adverse events and serious adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subject >= 18 years;
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Histologically or cytologically confirmed HER2-positive breast cancer defined as 3+ determined by validated IHC or positive by in situ hybridization (ISH);
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Early-stage (T1c or 2, N1, M0; T2 or 3, N0, M0) or locally advanced (T1c or 2 or 3, N2, M0; T3N1M0; T1c or 2 or 3, N3a or 3b, M0) breast cancer;
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Adequate organ function assessed within 7 days prior to first trial treatment;
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ECOG score 0 or 1;
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Left ventricular ejection fraction (LVEF) ≥ 55% at baseline;
Exclusion Criteria:
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Stage IV (metastatic) breast cancer;
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Inflammatory breast cancer;
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Previous anti-cancer therapy or radiotherapy for any malignancy;
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Major surgery for any reason within 28 days;
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History of uncontrolled intercurrent illness;
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Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance;
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Fudan University Cancer Hospital | Shanghai | Shanghai | China | 200000 |
Sponsors and Collaborators
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Investigators
- Principal Investigator: Jiong Wu, professor, Fudan University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KN026-208