A Study of BCD-135 in Patients With Advanced Solid Tumors

Melanoma Clinical Trial

Official title:

A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-135 (JSC BIOCAD, Russia) in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03464032
• Other study ID #: BCD-135-1
• Status: Recruiting
• Phase: Phase 1
• First received: March 7, 2018
• Last updated: March 12, 2018
• Start date: October 31, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: March 2018
• Source: Biocad
• Contact: Mariia Shustova, MD
• Phone: +7 (812) 380 49 33
• Email: shustova[@]biocad.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Safety, and Immunogenicity of BCD-135 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 cancer (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 or subsequent therapy lines);

• Locally advanced or metastatic EGFR/ALK wt NSCLC (squamous cell carcinoma/adenocarcinoma), progressive after the first-line therapy with platinum-based CT or EGFR/ALK wt NSCLC progressive after the first-line therapy with EGFR/ALK inhibitors (the drug will be used as a second therapy line);

• Metastatic clear cell renal carcinoma, progressive after at least the first-line therapy (the drug will be used as a second or third therapy lines);

• Locally advanced or metastatic bladder cancer progressive on/after therapy with platinum-based CT (the drug will be used as a second therapy line);

4. ECOG score of 0 to 1;

5. Presence of blocks for histological examination and/or patient's agreement to conduct a biopsy of an accessible lesions to obtain a histological material for examination of PD-L1 status

6. Measurable disease (at least one lesion) according to RECISTv.1.1;

7. 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);

8. No severe pathology of organs or systems;

9. Life expectancy of at least 12 weeks from the screening;

10. 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-100.

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, progressive or associated with clinical symptoms (e.g. cerebral edema or spinal cord compression). Exclusions: metastases that do not progress and do not require steroids and/or anticonvulsants within at least 4 weeks before randomization;

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. LDH level >2 ULN;

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

11. More than

• 2 therapy lines of unresectable/metastatic melanoma,

• 1 therapy line of metastatic NSCLC,

• 2 therapy lines of metastatic RCC;

• 1 therapy line of metastatic BC;

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 28 days before inclusion in the present study; previous participation in the present study.

16. Acute infections or active chronic infections;

17. Documented HIV infection;

18. Positive screening results for Hbs-antigen, hepatitis B core antibodies (anti-HBc Ab) and/or hepatitis C antibodies;

19. Positive results of microprecipitation reaction together with positive TPHA assay results at the screening;

20. Body weight > 100 kg.

21. Intravenous administration of the drug is impossible;

22. Intravenous administration of contrast agents is impossible;

23. Hypersensitivity to any component of BCD-100.

24. Known history of hypersensitivity to monoclonal antibodies;

25. Pregnancy or breastfeeding;

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Renal Cell
• Melanoma
• NSCLC
• Renal Cell Carcinoma
• Urinary Bladder Neoplasms

Intervention

Drug:
• BCD-135
Monoclonal anti-PD-L1 antibody

Locations

Country	Name	City	State
Russian Federation	LLC BioEk	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DCR	Disease control rate (CR+PR+SD). Pilot efficacy assessment is not the primary objective of this study and will be conducted by surrogate endpoints describing the direct antitumor effect of the drug.	85 days