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

Not Applicable

Recruiting

• Conditions: Triple Negative Breast Cancer
• Interventions: Biological: BCD-236; Drug: Chemotherapy

• Registration Number: NCT07108309
• Lead Sponsor: Biocad

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-15
• Status Verified: 2025-02
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-04
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-07
• Last Update Posted: 2025-08-07
• Primary Completion: 2025-12
• Study Completion: 2027-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 124

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCD-236 + Chemotherapy (CHT)	BCD-236	Subjects will receive BCD-236 +CHT Duration of treatment: until disease progression or intolerable toxicity or EOS
BCD-236 + Chemotherapy (CHT)	Chemotherapy	Subjects will receive BCD-236 +CHT Duration of treatment: until disease progression or intolerable toxicity or EOS
Chemotherapy (CHT)	Chemotherapy	Subjects will receive CHT. Duration of treatment: until disease progression or intolerable toxicity or EOS

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR)	24 weeks	According to RECIST 1.1 criteria by the central independent review (CIR)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	51 and 102 weeks	According to RECIST 1.1 criteria by the central independent review (CIR)
Overall survival (OS)	102 weeks
Disease control rate (DCR)	24 weeks	According to RECIST 1.1 criteria by the central independent review (CIR)
Time to response	24 weeks	According to RECIST 1.1 criteria by the central independent review (CIR)
Duration of response	24 weeks	According to RECIST 1.1 criteria by the central independent review (CIR)

Trial Locations

Locations (47)

Health Institution "Brest Regional Oncology Center"; 🇧🇾 Brest, Belarus

"Gomel Regional Clinical Oncology Dispensary"; 🇧🇾 Gomel, Belarus

Minsk City Oncology Center; 🇧🇾 Minsk, Belarus

State Budgetary Institution of Healthcare of the Arkhangelsk Region "Arkhangelsk Clinical Oncology Dispensary"; 🇷🇺 Arkhangel'sk, Russian Federation

Regional State Budgetary Healthcare Institution "Altai Regional Oncology Dispensary"; 🇷🇺 Barnaul, Russian Federation

SBHI "Chelyabinsk regional clinical center Oncology and nuclear medicines"; 🇷🇺 Chelyabinsk, Russian Federation

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, Russian Federation

SBHI of the Kaluga Region "Kaluga Regional Clinical Oncology Center"; 🇷🇺 Kaluga, Russian Federation

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, Russian Federation

SBHI "Clinical oncological Dispensary № 1" of the Ministry of Health of the Krasnodar Territory; 🇷🇺 Krasnodar, Russian Federation

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