BCD-267-1 “A double-blind comparative randomized phase I clinical trial to study the pharmacokinetics, safety, and immunogenicity of BCD-267 in monotherapy and a reference drug after single and multiple intravenous administration in patients with advanced breast cancer”.
The pharmacokinetics, pharmacodynamics, safety, and immunogenicity of BCD-267 (INN trastuzumab deruxtecan) and Enhertu® (INN trastuzumab deruxtecan) will be compared over the duration of the BCD-267-1 clinical trial following single and multiple intravenous administration to participants who:
Are aged 18 years and older.
Have documentary evidence (histological report) of breast cancer, which:
Previously received at least one line of anti-HER2 therapy for advanced or metastatic breast cancer followed by disease progression; or who had documented progression within 6 months of adjuvant treatment that included anti-HER2 therapy.
Have biomaterial for histological examination and/or agree to undergo a biopsy to determine HER2 status before randomization.
Have at least one measurable tumor lesion according to RECIST 1.1 criteria2 by central independent review.
Have an ECOG performance score of 0-13.
Have their laboratory test values consistent with adequate functions of organs and systems.
This study has exclusion criteria (criteria for non-eligibility for participation in a specific clinical trial), the full list of which will be communicated to the potential participant by the Clinical Investigator. In particular, the exclusion criteria are:
Prior therapy with trastuzumab deruxtecan.
Indications for radical therapy (excluding minor surgical operations or radiation therapy for palliative purposes).
Significant cardiovascular disease and/or deviations in laboratory or instrumental values in the opinion of the Clinical Investigator.
Spinal cord compression or clinically active central nervous system (CNS) metastases determined as untreated and symptomatic and/or requiring therapy with corticosteroids or anticonvulsants.
History of interstitial lung disease (ILD, non-infectious) / pneumonitis requiring glucocorticosteroids, or ILD/pneumonitis at the time of screening, or suspicion of ILD/pneumonitis on imaging during the screening period.
Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media).
The BCD-267-1 clinical trial is being conducted in study centers in various cities of the Russian Federation.
To query about participating in a clinical study, including contact details of study centers, please use a special form at ct.biocad.ru.
The Clinical Investigator will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study, as well as about other drug products used in the study. The potential participant should read the complete study information and consult with the Clinical Investigator and/or Treating Physician.
Clinical Study Authorization No. 75 dated February 14, 2025 of the Ministry of Health of the Russian Federation and the list of approved study centers are published in the State Register of Medicines.
HER2 is human epidermal growth factor receptors.
RECIST 1.1. (Response Evaluation Criteria in Solid Tumours) is a set of standardized criteria used to evaluate tumour size reduction in response to therapy.
The ECOG scale describes the patient’s level of functional status in terms of self-care ability, daily life and physical activity.