Phase I Study of BCD-145 (Anti-CTLA-4) in Patients With Unresectable/Metastatic Melanoma

NCT ID: NCT03472027

Last Updated: 2019-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-02
• Study Completion Date: 2018-12-04

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 Unresectable/Metastatic Melanoma.

Conditions

Melanoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BCD-145 Monotherapy Dose Level 1

Group Type: EXPERIMENTAL

BCD-145

Intervention Type: BIOLOGICAL

Anti-CTLA-4 monoclonal antibody, IV infusion

BCD-145 Monotherapy Dose Level 2

Group Type: EXPERIMENTAL

BCD-145

Intervention Type: BIOLOGICAL

Anti-CTLA-4 monoclonal antibody, IV infusion

BCD-145 Monotherapy Dose Level 3

Group Type: EXPERIMENTAL

BCD-145

Intervention Type: BIOLOGICAL

Anti-CTLA-4 monoclonal antibody, IV infusion

BCD-145 Monotherapy Dose Level 4

Group Type: EXPERIMENTAL

BCD-145

Intervention Type: BIOLOGICAL

Anti-CTLA-4 monoclonal antibody, IV infusion

BCD-145 Monotherapy Dose Level 5

Group Type: EXPERIMENTAL

BCD-145

Intervention Type: BIOLOGICAL

Anti-CTLA-4 monoclonal antibody, IV infusion

Interventions

BCD-145

Anti-CTLA-4 monoclonal antibody, IV infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Patient provides a written informed consent and is able to follow the requirements of the Protocol;

2. Age ≥ 18 years

3. 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);

4. ECOG score of 0 to 2;

5. Measurable disease (at least one lesion) according to RECIST v1.1 ;

6. 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);

7. No severe pathology of organs or systems;

8. Life expectancy of at least 16 weeks from the screening;

9. 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 Criteria

1. Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of >50% renal parenchyma);

2. Brain metastases ;

3. Severe cardiovascular disorders within 6 months before screening;

4. Autoimmune diseases;

5. Conditions requiring steroids or any other immunosuppressants;

6. Blood disorders: ANC ≤1,500/mm3; platelets ≤100,000/mm3; or Hb ≤90 g/L;

7. Renal function impairment: creatinine ≥1.5 × ULN;

8. Hepatic function impairment: bilirubin ≥1.5 × ULN; AST and ALT ≥2.5 × ULN (5 × ULN for patients with liver metastases), AlkPh ≥ 5 × ULN;

9. Endocrine disorders: abnormal thyroid hormones

10. Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);

11. Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);

12. Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;

13. Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;

14. Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);

15. 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.

16. Acute infections or active chronic infections;

17. Documented hepatitis B, active hepatitis C, HIV or syphilis infection;

18. Intravenous administration of the drug is impossible;

19. Intravenous administration of contrast agents is impossible;

20. Hypersensitivity to any component of BCD-145.

21. Known history of hypersensitivity to monoclonal antibodies;

22. Pregnancy or breastfeeding;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biocad

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roman A Ivanov, PhD

Role: STUDY_DIRECTOR

Vice President R&D, JSC BIOCAD

Locations

N.N. Blokhin National Medical Research Center of Oncology

Moscow, , Russia

JSC "Modern Medical Technologies"

Saint Petersburg, , Russia

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, , Russia

Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

BCD-145-1

Identifier Type: -

Identifier Source: org_study_id