BCD-236-1 "A Phase I, open-label, single-arm, dose-finding cohort study to evaluate the safety, pharmacokinetics, and preliminary efficacy of escalating intravenous doses of BCD-236 administered as monotherapy and in combination with anti-PD-1 therapy in subjects with malignant tumors".
During the clinical study BCD-236-1, the safety, immunogenicity and efficacy, pharmacokinetics, and pharmacodynamics of the investigational drug BCD-236 will be evaluated after its intravenous administration in ascending doses as monotherapy and in combination with anti-PD-11 therapy in subjects who:
Have a histologically verified diagnosis of one of the following malignancies:
High-grade2 serous ovarian cancer (high-grade serous adenocarcinoma of fallopian tubes and peritoneum is allowed).
Must agree to provide an archival tumor material for AXL receptor testing4.
Have at least one measurable lesion according to RECIST 1.15 criteria assessed by local examination.
Have documentary evidence of the following at the time of signing an informed consent form:
A disease that is resistant/refractory6 to platinum (progression during the therapy or within 6 months of the last platinum-containing regimen: cisplatin, or carboplatin, or oxaliplatin) in potential participants diagnosed with ovarian/fallopian tube/peritoneal cancer;
Confirmed progression during immunotherapy with checkpoint inhibitor(-s) (e.g., pebrolyzumab, nivolumab, etc.) and at least one line of tyrosine kinase inhibitors (e.g., axitinib, cabozantinib, sunitinib, etc.) in potential participants with renal cell cancer.
The clinical study protocol includes biopsy of an accessible tumor lesion as part of the study.
This clinical study has non-inclusion criteria (criteria for non-eligibility to participate in a particular clinical study); the full list will be provided to a potential participant by the Clinical Investigator. Among other factors, the non-inclusion criteria include the following:
No previous antitumor therapy or current indications for radical therapy (e.g., surgery);
Presence of active metastases to the CNS7 that have not been previously treated with local therapies (e.g., brain radiation therapy) or progression after local therapies or after radical treatment and the need for glucocorticoids or anticonvulsants.
Severe comorbidities (including autoimmune diseases) or uncontrolled complications of the underlying disease (e.g., frequently recurrent pleurisy or ascites).
History of severe immune-mediated complications secondary to previous therapy.
Severe hypersensitivity/allergic reactions to drugs (including contrast agents).
Hematologic abnormalities:
Absolute neutrophil count < 1.5 × 109/L
Platelets < 100 × 109/L
Hemoglobin ≤ 90 g/L
Renal impairment:
Serum creatinine > 1.5 × ULN (upper limit of normal)
Hepatic impairment:
Total bilirubin > 1.5 × ULN (except for the subjects with Gilbert’s syndrome who should have bilirubin levels not more than 50 μmol/L)
AST or ALT > 2.5 × ULN (5 × ULN for potential participants with liver metastases)
Alkaline phosphatase > 2.5 × ULN
Albumin < 2.8 g/dL
The clinical study BCD-236-1 is conducted in study centers of the Russian Federation, namely in St. Petersburg and Moscow.
To query about participating in a clinical study, including contact details of study centers, please use a special form at ct.biocad.ru.
The Clinical Investigator will tell the potential participant about other eligibility criteria and contraindications for participation in this clinical study, as well as about other drug products used in the study. The potential participant should read the complete study information and consult with the Clinical Investigator and (or) Treating Physician.
Clinical Study Authorization No. 363 dated July 13, 2023 of the Ministry of Health of the Russian Federation and the list of approved study centers in the territory of the Russian Federation are published in the State Register of Medicines.
anti-PD-1 — programmed cell death 1 inhibitors
High grade - Highly aggressive tumors that initially do not involve the muscle layer but can quickly spread to muscle tissues and begin to spread to other areas of the body if left untreated.
ECOG scale is a scale that determines the subject's functional status in terms of his/her ability to self-care, daily functioning, and physical activities.
AXL - receptor tyrosine kinase
RECIST (Response Evaluation Criteria in Solid Tumours) is a set of standardized criteria used to evaluate tumour size reduction in response to therapy.
Refractory disease is a disease that is resistant to previous therapy.