Clinical trial BCD-237-1 “A double-blind comparative randomized phase I clinical trial to study the pharmacokinetics, safety, and immunogenicity of BCD-237 in monotherapy and a reference drug after single and multiple intravenous administration in patients with locally advanced unresectable or metastatic breast cancer".
During the conduct of clinical trial BCD-237-1, a comparison will be conducted of the pharmacokinetics, safety, and immunogenicity of BCD-237 and Kadcyla® following single and multiple intravenous administrations in female participants who:
Are aged 18 years and older.
Have documentary evidence (histological report) of a diagnosis of breast cancer, which is HER2-positive1, and is classified as locally advanced unresectable or metastatic (either luminal or non-luminal).
Have previously received therapy with trastuzumab and taxanes (sequentially or in combination, including with other therapies) for locally advanced unresectable or metastatic breast cancer, followed by disease progression.
Have available tissue for histological evaluation and/or agree to undergo a biopsy for HER2 status determination prior to randomization.
Have at least one measurable lesion according to RECIST 1.1 criteria2, as assessed by central independent review.
Have an ECOG3 performance score of 0–1.
Have adequate organ and system function as demonstrated by laboratory test values.
The Clinical Study Protocol provides for the biopsy of an accessible tumor lesion or the review of archived tumor material (i.e., a sample collected prior to signing the Patient Information Sheet and Informed Consent Form) obtained after the last line of anti-HER2 therapy.
This clinical study has non-inclusion criteria (criteria for non-eligibility to participate in a particular clinical study); the full list will be provided to a potential participant by the Clinical Investigator. Among other factors, the non-inclusion criteria include the following:
Prior therapy with trastuzumab emtansine and/or trastuzumab deruxtecan.
Presence of indications for radical therapy (including surgery or radiotherapy) and availability of other therapeutic options considered by the investigator to be more effective than the investigational therapy.
Clinically significant cardiovascular disease and/or abnormalities in laboratory or instrumental findings, as assessed by the investigator.
Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic and/or requiring treatment with glucocorticoids or antiepileptic drugs.
History of interstitial lung disease (ILD) of non-infectious origin or pneumonitis requiring glucocorticoid therapy, or presence of ILD/pneumonitis at the time of screening4, or suspected ILD/pneumonitis based on imaging during screening.
Impossibility to administer intravenous contrast agents (including due to hypersensitivity to contrast media).
History of severe polyneuropathy.
The clinical trial BCD-237-1 is being conducted at study centers in multiple cities across the Russian Federation.
To query about participating in a clinical trial, including contact details of study centers, please use special form at ct.biocad.ru.
The Clinical Investigator will tell the potential participant about other eligibility criteria and contraindications to participation in this clinical trial. The potential participant should read the complete study information and consult with the Physician Investigator and/or their Attending Physician.
Clinical Study Authorization No. 164 dated April 09, 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.
Human epidermal growth factor receptor 2.
RECIST (eng. (Response Evaluation Criteria in Solid Tumours) is a set of standardized criteria used to evaluate tumour size reduction in response to therapy.
ECOG scale is a scale that determines the subject's functional status in terms of his/her ability to self-care, daily functioning, and physical activities.
Screening is a specific time period aimed at the evaluation of a subject's eligibility to participate in a clinical study according to the eligibility criteria based on the results of diagnostic procedures and expert opinions.