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

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

INTRODUCTION

  • Org Study ID: BCD-135-1
  • Secondary ID: N/A
  • NTC ID: NCT03464032
  • Sponsor: Biocad

BRIEF 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


  • Overall Status
    Recruiting
  • Start Date
    October 31, 2017
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: DCR

Primary Outcome 1 - Timeframe: 85 days

CONDITION

  • Melanoma
  • NSCLC
  • Renal Cell Carcinoma
  • Bladder Cancer

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;

Gender: All

Minimum Age: N/A

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Svetlana Odintsova, MD

Role: Principal Investigator

Affiliation: LLC BioEk

Overall Contact

Name: Svetlana Odintsova, MD

Phone: +7 (812) 380 49 33

Email: shustova@biocad.ru

LOCATION

Facility Status Contact
Facility: LLC BioEk
Saint-Petersburg,
Russian Federation 		Status: Recruiting Contact:
Svetlana Odintsova, MD
+78129452232

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