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BCD-236 plus chemotherapy for relapsed or metastatic triple negative breast cancer

A Randomized, Open-label, Comparative Clinical Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer

Phase 2 Interventional Biocad · NCT07108309

This trial will try BCD-236 together with chemotherapy to see if it helps people with relapsed or metastatic triple negative breast cancer whose tumors show AXL.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment124 (estimated)
Ages18 Years to 74 Years
SexFemale
SponsorBiocad Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations47 sites (Brest and 46 other locations)
Trial IDNCT07108309 on ClinicalTrials.gov

What this trial studies

This is a phase 2 interventional trial testing the investigational agent BCD-236 in combination with standard chemotherapeutic agents for adults with relapsed or metastatic triple negative breast cancer. Eligible participants must have tumor AXL expression confirmed by immunohistochemistry and have received at least one prior line of systemic therapy; a fresh tumor sample is required for screening. The study will collect data on tumor response, safety and tolerability, pharmacokinetics, and immunogenicity while participants receive the combination regimen. Treatment and follow-up visits will occur at regional oncology centers in Belarus.

Who should consider this trial

Good fit: Adults aged 18 to under 75 with relapsed or metastatic triple negative breast cancer who have had at least one prior systemic therapy and have confirmed AXL expression on a fresh tumor sample are the intended participants.

Not a fit: Patients whose tumors do not express AXL, those who are hormone-receptor or HER2 positive, medically unfit for chemotherapy, or older than the trial age limit are unlikely to benefit from this specific approach.

Why it matters

Potential benefit: If successful, the combination could shrink tumors or prolong the time before disease progresses in AXL-positive relapsed or metastatic TNBC patients.

How similar studies have performed: AXL-targeting approaches have shown preclinical promise and limited signals in early-phase clinical work, but no large trials have yet demonstrated clear, definitive benefit in TNBC.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Brest and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Triple Negative Breast Cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.