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

March 12, 2018 updated by: Biocad

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mariia Shustova, MD
  • Phone Number: 651 +7 (812) 380 49 33
  • Email: shustova@biocad.ru

Study Locations

  • Russian Federation
      • Saint-Petersburg, Russian Federation
        • Recruiting
        • LLC BioEk
        • Contact:
          • Svetlana Odintsova, MD
          • Phone Number: +78129452232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BCD-135
Dose-escalation Arm (0.4, 1, 3, 10, 20 mg/kg)
Drug: BCD-135
Monoclonal anti-PD-L1 antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCR
Time Frame: 85 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocad

Investigators

  • Principal Investigator: Svetlana Odintsova, MD, LLC BioEk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2017

Primary Completion (Anticipated)

May 31, 2018

Study Completion (Anticipated)

October 31, 2018

Study Registration Dates

First Submitted

March 7, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCD-135-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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