BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer

Launched by BIOCAD · Aug 4, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called BCD-236 combined with chemotherapy for women with a type of breast cancer known as triple negative breast cancer (TNBC) that has come back or spread to other parts of the body. The study aims to find out how effective and safe this combination is, how the body processes the treatment, and whether the immune system reacts to it. This trial is currently looking for participants.

Women who may join this study are between 18 and 74 years old and have a confirmed diagnosis of TNBC that has progressed or returned after previous treatments. They must have had at least one prior treatment for advanced or metastatic disease and show certain characteristics in their tumor, including the presence of a protein called AXL. Participants will need to have measurable tumors and be in generally good health with a life expectancy of at least four months. Those with active brain cancer spread usually cannot join unless their brain metastases have been treated and are stable. If you join, you can expect to receive BCD-236 along with chemotherapy and undergo regular check-ups to monitor how well the treatment is working and to watch for any side effects.

Gender

FEMALE

Eligibility criteria

• Main Inclusion Criteria:
• • Signed informed consent and the subject's ability to comply with the requirements of the Clinical Study Protocol.
• • Age ≥18 years and \<75 years at the time of signing the informed consent form.
• • Histologically verified diagnosis (there are documented results of relevant studies) of TNBC: ER 0-2 points, PR 0-2 points or ER \<1%, PR \<1% (ASCO/CAP); HER2 (≤1+) or HER2 (2+) in the absence of amplification of the Her-2-neu gene by ISH.
• • TNBC is progressive or relapsing on or after systemic therapy.
• • The subject received at least 1 line of systemic therapy for locally advanced unresectable or metastatic TNBC, or she experienced a relapse / progressive disease during or within 6 months after completion of post-operative (adjuvant) chemotherapy.
• • Confirmed AXL expression in tumor cells according to immunohistochemistry.
• • Availability of fresh (obtained as part of screening or before its start, but after disease progression or relapse on the last line of therapy) and archival (obtained before disease progression or relapse on the last line of therapy, if available) tumor material samples suitable for immunohistochemical examination to determine AXL expression.
• • Presence of at least 1 measurable tumor lesion according to RECIST 1.1. criteria for CIR.
• • ECOG score 0-1.
• • Life expectancy ≥ 4 months from the date of signing of the informed consent form in the opinion of the Investigator.
• Main Exclusion Criteria:
• • Indications for radical therapy or radiotherapy (excluding minor surgery or radiation therapy for palliative purposes).
• • Active CNS metastases and/or carcinomatous meningitis. Subjects with brain metastases may participate in the study provided that the metastases have been adequately treated with surgery or radiotherapy, and if they have been clinically stable for at least 4 weeks prior to randomization (i.e. no neurological symptoms, no need for corticosteroids, and no lesions \>1.5 cm) and no evidence of new or increasing CNS metastases. Patients with newly diagnosed CNS metastases during screening may not be included in the study.