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

Status: Recruiting
Location: See all (47) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belarus
Health Institution Brest Regional Oncology Center
RECRUITING
Brest
Gomel Regional Clinical Oncology Dispensary
RECRUITING
Homyel
Minsk City Oncology Center
RECRUITING
Minsk
Russian Federation
State Budgetary Institution of Healthcare of the Arkhangelsk Region Arkhangelsk Clinical Oncology Dispensary
ACTIVE_NOT_RECRUITING
Arkhangelsk
Regional State Budgetary Healthcare Institution Altai Regional Oncology Dispensary
ACTIVE_NOT_RECRUITING
Barnaul
SBHI Chelyabinsk regional clinical center Oncology and nuclear medicines
RECRUITING
Chelyabinsk
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
RECRUITING
Izhevsk
SBHI of the Kaluga Region Kaluga Regional Clinical Oncology Center
RECRUITING
Kaluga
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
RECRUITING
Kazan'
SBHI Clinical oncological Dispensary № 1 of the Ministry of Health of the Krasnodar Territory
RECRUITING
Krasnodar
Branch of company Hadassah Medical LCC
RECRUITING
Moscow
Federal State Budgetary Scientific Institution Russian Scientific Center of Surgery named after Academician B.V. Petrovsky
RECRUITING
Moscow
FSAEI of Higher Education First Moscow State Medical University named after I.M. Sechenov of the Ministry of Health of the Russian Federation
RECRUITING
Moscow
FSAEI of Higher Education I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation (Sechenov University)
RECRUITING
Moscow
FSAI National Medical Research Center for Therapeutic and Rehabilitation Center of the Ministry of Health of the Russian Federation
RECRUITING
Moscow
FSBI Lopukhin Federal Research and Clinical Center of Physical-Chemical Medicine of Federal Medical Biological Agency
RECRUITING
Moscow
FSBI National Medical Research Center of Oncology named after N. N. Blokhin of the Ministry of Health of the Russian Federation
RECRUITING
Moscow
Joint Stock Company Medsi Group of Companies
RECRUITING
Moscow
JSC Modern medical technologies
RECRUITING
Moscow
Limited Liability Company Moscow Center for Rehabilitation Treatment
RECRUITING
Moscow
SBHI of the City of Moscow Moscow Clinical Scientific and Practical Center named after A.S. Loginov of the Moscow City Health Department
RECRUITING
Moscow
State Budgetary Institution of Healthcare of the City of Moscow City Clinical Hospital named after S.S. Yudin of the Moscow City Health Department
RECRUITING
Moscow
State Budgetary Institution of Healthcare of the City of Moscow Moscow City Oncology Hospital No. 62 of the Moscow City Healthcare Department
RECRUITING
Moscow
SAHI of the Nizhny Novgorod region Research Institute of Clinical Oncology Nizhny Novgorod Regional Clinical Oncological Dispensary
RECRUITING
Nizhny Novgorod
FBHI of the Novosibirsk Region Novosibirsk Regional Clinical Oncological Dispensary
RECRUITING
Novosibirsk
FSBI National Medical Research Center for Radiology of the Ministry of Health of the Russian Federation
RECRUITING
Obninsk
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
ACTIVE_NOT_RECRUITING
Obninsk
Budget Healthcare Institution of the Omsk region Clinical Oncological Dispensary
RECRUITING
Omsk
FSBI National Medical Research Center of Oncology of the Ministry of Health of the Russian Federation
RECRUITING
Rostov-on-don
State budgetary institution of the Ryazan region Regional clinical oncology dispensary
RECRUITING
Ryazan
FSBEI of Higher Education North-Western State Medical University named after I. I. Mechnikov of the Ministry of Health of the Russian Federation
RECRUITING
Saint Petersburg
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
RECRUITING
Saint Petersburg
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
RECRUITING
Saint Petersburg
LLC NRC Eco-Safety
RECRUITING
Saint Petersburg
LLC VitaMed
RECRUITING
Saint Petersburg
Private healthcare institution Clinical hospital RZD-Medicine of the city of St. Petersburg
RECRUITING
Saint Petersburg
Private medical institution Euromedservice
RECRUITING
Saint Petersburg
SBHI of St. Petersburg City Clinical Oncology Dispensary
RECRUITING
Saint Petersburg
SBHI St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological) named after N.P. Napalkov
RECRUITING
Saint Petersburg
State Budgetary Healthcare Institution Leningrad Regional Clinical Hospital
ACTIVE_NOT_RECRUITING
Saint Petersburg
Federal State Budgetary Educational Institution of Higher Education National Research Mordovian State University named after N.P. Ogarev
RECRUITING
Saransk
SBHI Arkhangelsk Region Severodvinsk City Clinical Hospital No. 2 for Emergency Medicine
RECRUITING
Severodvinsk
State Budgetary Healthcare Institution Tambov Regional Oncology Clinical Dispensary
ACTIVE_NOT_RECRUITING
Tambov
SAHI Republican Clinical Oncology Dispensary of the Ministry of Health of the Republic of Bashkortostan
RECRUITING
Ufa
SBHI Volgograd Regional Clinical Oncological Dispensary
ACTIVE_NOT_RECRUITING
Volgograd
SBHI of the Yaroslavl region Regional Clinical Oncological Hospital
RECRUITING
Yaroslavl
SAHI of the Sverdlovsk region Sverdlovsk Regional Oncological Center
ACTIVE_NOT_RECRUITING
Yekaterinburg
Contact Information
Primary
Evgenia А Mikhailova
mikhailova@biocad.ru
+7 911 081 23 68
Time Frame
Start Date: 2024-07-15
Estimated Completion Date: 2027-05
Participants
Target number of participants: 124
Treatments
Experimental: BCD-236 + Chemotherapy (CHT)
Subjects will receive BCD-236 +CHT~Duration of treatment: until disease progression or intolerable toxicity or EOS
Active_comparator: Chemotherapy (CHT)
Subjects will receive CHT.~Duration of treatment: until disease progression or intolerable toxicity or EOS
Sponsors
Leads: Biocad

This content was sourced from clinicaltrials.gov

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