NCT07108309 BCD-236 in Combination With Chemotherapy in Patients With Relapsed and/or Metastatic Triple Negative Breast Cancer
| NCT ID | NCT07108309 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Biocad |
| Condition | Triple Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 124 participants |
| Start Date | 2024-07-15 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 124 participants in total. It began in 2024-07-15 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To study the efficacy, safety, pharmacokinetics and immunogenicity of BCD-236 in combination with chemotherapeutic agents (CHT) in 2nd and subsequent lines of therapy of subjects with relapsed and/or metastatic triple negative breast cancer (TNBC).
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.
Contact & Investigator
Arina V Zinkina-Orikhan, PhD
STUDY DIRECTOR
Director of Clinical Development Department, BIOCAD
Frequently Asked Questions
Who can join the NCT07108309 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 74 Years, studying Triple Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07108309 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07108309 currently recruiting?
Yes, NCT07108309 is actively recruiting participants. Contact the research team at mikhailova@biocad.ru for enrollment information.
Where is the NCT07108309 trial being conducted?
This trial is being conducted at Brest, Belarus, Homyel, Belarus, Minsk, Belarus, Arkhangelsk, Russia and 11 additional locations.
Who is sponsoring the NCT07108309 clinical trial?
NCT07108309 is sponsored by Biocad. The principal investigator is Arina V Zinkina-Orikhan, PhD at Director of Clinical Development Department, BIOCAD. The trial plans to enroll 124 participants.
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