Status:
COMPLETED
Phase I Study of BCD-145 (Anti-CTLA-4) in Patients With Unresectable/Metastatic Melanoma
Lead Sponsor:
Biocad
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-145 (JSC BIOCAD, Russia) Monotherapy in Patients with Unresectab...
Eligibility Criteria
Inclusion
- Patient provides a written informed consent and is able to follow the requirements of the Protocol;
- Age ≥ 18 years
- Histologically confirmed (well-documented test results; preferably, block specimens available) unresectable (stage III/IV) or metastatic (stage IV) melanoma (the drug will be used as the first of subsequent therapy lines);
- ECOG score of 0 to 2;
- Measurable disease (at least one lesion) according to RECIST v1.1 ;
- Resolved toxicity events from the previous therapy or adverse consequences of surgical interventions to ≤ grade 1 CTCAE v. 4.03, except for chronic/irreversible adverse events not affecting the safety of the study therapy (e.g. alopecia);
- No severe pathology of organs or systems;
- Life expectancy of at least 16 weeks from the screening;
- Patients of childbearing potential enrolled in the study must agree to use reliable contraception methods throughout the study period, beginning 2 weeks before the inclusion in the study and up to 8 weeks after the last dose of BCD-145.
Exclusion
- Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of \>50% renal parenchyma);
- Brain metastases ;
- Severe cardiovascular disorders within 6 months before screening;
- Autoimmune diseases;
- Conditions requiring steroids or any other immunosuppressants;
- Blood disorders: ANC ≤1,500/mm3; platelets ≤100,000/mm3; or Hb ≤90 g/L;
- Renal function impairment: creatinine ≥1.5 × ULN;
- Hepatic function impairment: bilirubin ≥1.5 × ULN; AST and ALT ≥2.5 × ULN (5 × ULN for patients with liver metastases), AlkPh ≥ 5 × ULN;
- Endocrine disorders: abnormal thyroid hormones
- Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);
- Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);
- Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;
- Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;
- Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);
- Simultaneous participation in any other clinical trial; participation in other clinical trials within 30 days before inclusion in the present study; previous participation in the present study.
- Acute infections or active chronic infections;
- Documented hepatitis B, active hepatitis C, HIV or syphilis infection;
- Intravenous administration of the drug is impossible;
- Intravenous administration of contrast agents is impossible;
- Hypersensitivity to any component of BCD-145.
- Known history of hypersensitivity to monoclonal antibodies;
- Pregnancy or breastfeeding;
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2018
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03472027
Start Date
October 2 2017
End Date
December 4 2018
Last Update
May 9 2019
Active Locations (4)
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1
N.N. Blokhin National Medical Research Center of Oncology
Moscow, Russia, 115478
2
JSC "Modern Medical Technologies"
Saint Petersburg, Russia, 190013
3
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, Russia, 197758
4
Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Saint Petersburg, Russia, 197758