BCD-236-1

An Open-Label, Non-Comparative Phase 1 Cohort Study to Select a Dose and Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of BCD-236 when Administered Intravenously in Escalating Doses Alone and in Combination with Anti-PD-1 Therapy in Subjects with Malignant Neoplasms.

The aim of this clinical study is to assess the safety, immunogenicity, efficacy, pharmacokinetics, and pharmacodynamics of BCD-236 and to choose a dosing regimen for a subsequent phase 2 clinical study, after intravenous administration of BCD-236 in escalating doses alone and in combination with anti-PD-1 therapy¹ in participants who:

• Have reached the age of 18 years;
• Have a histologically confirmed diagnosis of one of the following malignant neoplasms: triple-negative breast cancer, ovarian cancer, kidney cancer, cutaneous melanoma (documented results of relevant tests are available);
• Have received at least first-line standard systemic therapy for advanced, unresectable, recurrent, or metastatic cancer;
• Have at least one measurable tumor lesion according to the RECIST criteria²;
• Have ECOG score 0–1³.

This clinical study has exclusion criteria (precluding participation in this clinical study), which will all be explained to the potential participant by the study doctor. In particular, the exclusion criteria are:

• Indications for radical therapy (including surgery, radiotherapy).
• Availability of other therapeutic options that, in the opinion of the study doctor, are more efficient than the therapy being studied.
• Active CNS metastases and/or carcinomatous meningitis. Subjects with brain metastases are allowed to participate in the clinical study if appropriate therapy has been administered, there are no clinical manifestations, and the use of glucocorticoids is not required; two CT/MRI scans with intravenous contrast enhancement performed at least 4 weeks apart (the second one performed during the screening) demonstrate no progression in metastatic brain lesions.
• Concomitant cancers, except radically treated cancer with a duration of remission of more than 5 years before the start of the study therapy. The exception is radically removed cervical carcinoma in situ⁴ or radically resected basal cell/squamous cell carcinoma.
• Severe concomitant diseases, life-threatening acute complications of the primary disease (including severe pleural, pericardial, or peritoneal effusion requiring intervention, pulmonary lymphangitis, bleeding, and organ perforation) at the time of signing the Informed Consent Form and during the screening period.
• Active, known or suspected autoimmune diseases (subjects with type 1 diabetes mellitus and hypothyroidism requiring only hormone replacement therapy, as well as skin diseases (vitiligo, alopecia, or psoriasis) that do not require systemic therapy, are allowed to participate).

The BCD-236-1 study is taking place in study centers in cities of the Russian Federation, such as St. Petersburg and Moscow.

You can ask questions about participation in the clinical study and request the contact information of study centers through the “Any questions?” form.

The study doctor will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study. The potential participant should read the full information about the study and consult the study doctor and/or attending physician.

Clinical Study Authorization No. 363 of the Ministry of Health of the Russian Federation dated July 13, 2023, and the list of approved study centers in the Russian Federation have been published in the State Registry of Medicines.

1. PD-1 (programmed cell death 1) inhibitors.
2. RECIST (Response Evaluation Criteria in Solid Tumors) is a set of standardized criteria used to evaluate tumor shrinkage in response to therapy.
3. ECOG scale measures the performance status of the patient in terms of his/her ability to take care of himself/herself, daily activities, and physical activity.
4. The term “in situ”, translated from Latin as “in the original place”, is used in oncology to refer to a tumor in the initial stage of development.