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

Main Inclusion Criteria:

• Signed informed consent and the subject's ability to comply with the requirements ofthe 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+) orHER2 (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 advancedunresectable or metastatic TNBC, or she experienced a relapse / progressive diseaseduring 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 afterdisease progression or relapse on the last line of therapy) and archival (obtainedbefore disease progression or relapse on the last line of therapy, if available)tumor material samples suitable for immunohistochemical examination to determine AXLexpression.

• Presence of at least 1 measurable tumor lesion according to RECIST 1.1. criteria forCIR.

• ECOG score 0-1.

• Life expectancy ≥ 4 months from the date of signing of the informed consent form inthe opinion of the Investigator.

Main Exclusion Criteria:

• Indications for radical therapy or radiotherapy (excluding minor surgery orradiation therapy for palliative purposes).

• Active CNS metastases and/or carcinomatous meningitis. Subjects with brainmetastases may participate in the study provided that the metastases have beenadequately treated with surgery or radiotherapy, and if they have been clinicallystable 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 orincreasing CNS metastases. Patients with newly diagnosed CNS metastases duringscreening may not be included in the study.