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

NCT07108309 | Recruiting Phase 2 DMC

• 1 other identifier: BCD-236-2
• Study Type: interventional
• Target: 124
• Locations: 2 countries
• Sites: 47

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).

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  According to RECIST 1.1 criteria by the central independent review (CIR)

  24 weeks

Secondary Outcomes (5)

• Progression-free survival (PFS)

  51 and 102 weeks

• Overall survival (OS)

  102 weeks

• Disease control rate (DCR)

  24 weeks

• Time to response

  24 weeks

• Duration of response

  24 weeks

Study Arms (2)

BCD-236 + Chemotherapy (CHT)

EXPERIMENTAL

Subjects will receive BCD-236 +CHT Duration of treatment: until disease progression or intolerable toxicity or EOS

Biological: BCD-236; Drug: Chemotherapy

Chemotherapy (CHT)

ACTIVE COMPARATOR

Subjects will receive CHT. Duration of treatment: until disease progression or intolerable toxicity or EOS

Drug: Chemotherapy

Interventions

BCD-236 BIOLOGICAL

as an intravenous infusion

BCD-236 + Chemotherapy (CHT)

Chemotherapy DRUG

CHT (at the investigator's discretion):

BCD-236 + Chemotherapy (CHT); Chemotherapy (CHT)

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biocad: lead

Study Sites (47)

Health Institution "Brest Regional Oncology Center"

Brest, Belarus

RECRUITING

"Gomel Regional Clinical Oncology Dispensary"

Homyel, Belarus

RECRUITING

Minsk City Oncology Center

Minsk, Belarus

RECRUITING

State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"

Arkhangelsk, Russia

ACTIVE NOT RECRUITING

Regional State Budgetary Healthcare Institution "Altai Regional Oncology Dispensary"

Barnaul, Russia

ACTIVE NOT RECRUITING

SBHI "Chelyabinsk regional clinical center Oncology and nuclear medicines"

Chelyabinsk, Russia

RECRUITING

Budgetary healthcare institution of the Udmurt Republic "Republican clinical oncology dispensary named after Sergei Grigorievich Primushko of the Ministry of Health of the Udmurt Republic

Izhevsk, Russia

RECRUITING

SBHI of the Kaluga Region "Kaluga Regional Clinical Oncology Center"

Kaluga, Russia

RECRUITING

State Autonomous Institution of Health "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan named after prof. M.Z.Sigal"

Kazan', Russia

RECRUITING

SBHI "Clinical oncological Dispensary № 1" of the Ministry of Health of the Krasnodar Territory

Krasnodar, Russia

RECRUITING

Branch of company "Hadassah Medical LCC"

Moscow, Russia

RECRUITING

Federal State Budgetary Scientific Institution "Russian Scientific Center of Surgery named after Academician B.V. Petrovsky"

Moscow, Russia

RECRUITING

FSAEI of Higher Education "First Moscow State Medical University named after I.M. Sechenov" of the Ministry of Health of the Russian Federation

Moscow, Russia

RECRUITING

FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)

Moscow, Russia

RECRUITING

FSAI "National Medical Research Center for Therapeutic and Rehabilitation Center" of the Ministry of Health of the Russian Federation

Moscow, Russia

RECRUITING

FSBI "Lopukhin Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency"

Moscow, Russia

RECRUITING

FSBI "National Medical Research Center of Oncology named after N. N. Blokhin" of the Ministry of Health of the Russian Federation

Moscow, Russia

RECRUITING

Joint Stock Company "Medsi Group of Companies"

Moscow, Russia

RECRUITING

JSC "Modern medical technologies"

Moscow, Russia

RECRUITING

Limited Liability Company "Moscow Center for Rehabilitation Treatment"

Moscow, Russia

RECRUITING

SBHI of the City of Moscow "Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department"

Moscow, Russia

RECRUITING

State Budgetary Institution of Healthcare of the City of Moscow "City Clinical Hospital named after S.S. Yudin of the Moscow City Health Department

Moscow, Russia

RECRUITING

State Budgetary Institution of Healthcare of the City of Moscow "Moscow City Oncology Hospital No. 62 of the Moscow City Healthcare Department"

Moscow, Russia

RECRUITING

SAHI of the Nizhny Novgorod region "Research Institute of Clinical Oncology "Nizhny Novgorod Regional Clinical Oncological Dispensary"

Nizhny Novgorod, Russia

RECRUITING

FBHI of the Novosibirsk Region "Novosibirsk Regional Clinical Oncological Dispensary"

Novosibirsk, Russia

RECRUITING

FSBI "National Medical Research Center for Radiology" of the Ministry of Health of the Russian Federation

Obninsk, Russia

RECRUITING

FSBI "National Medical Research Center of Radiology" of the Ministry of Health of the Russian Federation Medical Radiological Research Center named after A.F. Tsyb

Obninsk, Russia

ACTIVE NOT RECRUITING

Budget Healthcare Institution of the Omsk region "Clinical Oncological Dispensary"

Omsk, Russia

RECRUITING

FSBI "National Medical Research Center of Oncology" of the Ministry of Health of the Russian Federation

Rostov-on-Don, Russia

RECRUITING

State budgetary institution of the Ryazan region "Regional clinical oncology dispensary"

Ryazan, Russia

RECRUITING

FSBEI of Higher Education "North-Western State Medical University named after I. I. Mechnikov" of the Ministry of Health of the Russian Federation

Saint Petersburg, Russia

RECRUITING

FSBI "National medical research center of Oncology named after N.N. Petrov" Of Ministry of Health of the Russian Federation, Department of Breast Cancer Surgery

Saint Petersburg, Russia

RECRUITING

FSBI "National medical research center of Oncology named after N.N. Petrov" Of Ministry of Health of the Russian Federation, Research Division of Innovative Techniques in Medical Oncology and Rehabilitation Medicine

Saint Petersburg, Russia

RECRUITING

LLC "NRC Eco-Safety"

Saint Petersburg, Russia

RECRUITING

LLC "VitaMed"

Saint Petersburg, Russia

RECRUITING

Private healthcare institution "Clinical hospital "RZD-Medicine" of the city of St. Petersburg"

Saint Petersburg, Russia

RECRUITING

Private medical institution "Euromedservice"

Saint Petersburg, Russia

RECRUITING

SBHI "St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological) named after N.P. Napalkov"

Saint Petersburg, Russia

RECRUITING

SBHI of St. Petersburg "City Clinical Oncology Dispensary"

Saint Petersburg, Russia

RECRUITING

State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital

Saint Petersburg, Russia

ACTIVE NOT RECRUITING

Federal State Budgetary Educational Institution of Higher Education "National Research Mordovian State University named after N.P. Ogarev"

Saransk, Russia

RECRUITING

SBHI Arkhangelsk Region "Severodvinsk City Clinical Hospital No. 2 for Emergency Medicine"

Severodvinsk, Russia

RECRUITING

State Budgetary Healthcare Institution "Tambov Regional Oncology Clinical Dispensary"

Tambov, Russia

ACTIVE NOT RECRUITING

SAHI Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Bashkortostan

Ufa, Russia

RECRUITING

SBHI "Volgograd Regional Clinical Oncological Dispensary"

Volgograd, Russia

ACTIVE NOT RECRUITING

SBHI of the Yaroslavl region "Regional Clinical Oncological Hospital"

Yaroslavl, Russia

RECRUITING

SAHI of the Sverdlovsk region "Sverdlovsk Regional Oncological Center"

Yekaterinburg, Russia

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Arina V Zinkina-Orikhan, PhD

  Director of Clinical Development Department, BIOCAD

  STUDY DIRECTOR

Central Study Contacts

Evgenia А Mikhailova

CONTACT

+7 911 081 23 68; mikhailova@biocad.ru

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 7, 2025
• Study Start: July 15, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-02

Locations

RU (44); BE (3)