BCD-237-2/CHRYSALIS “A Phase III Double-Blind, Comparative Clinical Trial with Randomized Assignment to Evaluate the Efficacy and Safety of BCD-237 versus an Active Comparator in Patients with Advanced Breast Cancer.”

During the BCD-237-2/CHRYSALIS clinical trial, the comparability of efficacy and the similarity of safety and immunogenicity profiles of BCD-237 and the active comparator will be assessed following multiple intravenous administrations to subjects with locally advanced unresectable or metastatic HER2-positive (HER2+) breast cancer (BC) who:

Are at least 18 years of age at the time of signing the informed consent form;
Have documentary evidence of a diagnosis (histological conclusion) of “breast cancer” that:
- is locally advanced, unresectable, or metastatic;
- is HER2¹-positive (luminal/non-luminal) for its molecular biological subtype;
- the subject experienced disease progression during or within 6 months after treatment with trastuzumab and taxanes (in any line of therapy, sequentially or in combination, including adjuvant therapy), which was received for locally advanced unresectable or metastatic breast cancer; trastuzumab and taxanes may be used in combination with other therapies;
have documentary evidence of radiographic progression, with radical treatment no longer feasible;
have at least one measurable tumor lesion per RECIST 1.1 criteria² by independent central review;
have an ECOG performance status of 0–1³;
have laboratory test results consistent with adequate organ and system function.

The clinical trial protocol requires a biopsy of an accessible tumor lesion or a review of archival tumor material (i.e., a tumor sample collected prior to signing of the Clinical Trial Participant Information Sheet with the Informed Consent Form).

This clinical trial includes exclusion criteria (criteria that disqualify an individual from participation in this specific trial), and the investigator will provide the full list to potential participants. In particular, the exclusion criteria are:

Prior treatment with trastuzumab deruxecan or trastuzumab emtansine;
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;
Uncontrolled or clinically significant cardiovascular diseases and/or abnormalities in laboratory or diagnostic test results, in the opinion of the investigator;
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;
Spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic and/or requiring treatment with glucocorticoids or anticonvulsants;
A history of myelodysplastic syndrome, acute myeloid leukemia, or other malignancies, with the exception of: carcinoma in situ or non-melanoma skin cancer; a history of malignancies considered radically treated more than 3 years prior to the anticipated start of study therapy; Stage 0 or 1 malignancies that, in the opinion of the investigator, are considered radically treated and have a low risk of progression or recurrence; contralateral breast cancer with the HER2+ molecular subtype;
Inability to undergo intravenous contrast administration (including due to hypersensitivity to contrast agents);
A history of severe polyneuropathy.

If necessary, in consultation with the investigator and with the consent of the clinical trial participant, transportation services for relevant travel, as well as accommodation services for study visits, may be provided as part of the BCD-237-2/CHRYSALIS clinical trial. Reimbursement for transportation and accommodation expenses related to participation in the BCD-237-2/CHRYSALIS clinical trial is provided by JSC BIOCAD.

The BCD-237-2/CHRYSALIS clinical trial is being conducted at study sites in various cities of the Russian Federation, including Moscow, St. Petersburg, Nizhny Novgorod, Saratov, Yaroslavl, Yekaterinburg, Tomsk, Rostov-on-Don, Arkhangelsk, Krasnoyarsk, Pyatigorsk, Kirov, Sochi, Volgograd, Samara, Ryazan, Novosibirsk, Krasnodar, Pskov, Ivanovo, Orel, Omsk, Kaluga, Tver, Ufa, Kazan, Saransk, Kemerovo, Perm, Chelyabinsk.

You can ask questions about participating in the clinical trial, including requesting contact information for the study centers, using the dedicated form on the website ct.biocad.ru.

The investigator will explain the other eligibility criteria and contraindications for participation in this clinical trial to the potential participant. A potential participant should review the complete information about the study and consult with the investigator and/or their treating physician.

The Permit of the Ministry of Health of the Russian Federation for this clinical trial, No. 175, dated April 30, 2026, and the list of approved study sites have been published in the State Register of Medicines.

The Resolution of the Ministry of Health of the Republic of Belarus to conduct this clinical trial, No. 142/742/2026 dated June 23, 2026, and the list of approved study sites in the Republic of Belarus have been published in the State Register of Clinical Trials of the Republic of Belarus.

HER2 is the human epidermal growth factor receptor type 2.
RECIST (Response Evaluation Criteria in Solid Tumors) is a set of standardized criteria used to assess tumor shrinkage in response to therapy.
ECOG is a scale that describes a patient's performance status in terms of their ability to care for themselves, daily activities, and physical activity.
Screening is a specific period of time intended to evaluate a subject’s eligibility to participate in a clinical trial based on eligibility criteria and the results of diagnostic procedures and specialist consultations.

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BCD-237-2/CHRYSALIS