A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of BCD-100 in Patients With Advanced Solid Tumors

• ClinicalTrials.gov Identifier: NCT03050047
• Recruitment Status: Unknown
• First Posted: February 10, 2017
• Last Update Posted: August 31, 2018
• Sponsor: Biocad
• Information provided by (Responsible Party): Biocad

Study Description

Brief Summary:

A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients with Advanced Solid Tumors

Condition or disease	Intervention/treatment	Phase
Melanoma; Lung Cancer; Renal Cell Carcinoma	Biological: BCD-100	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter Open-Label Single-Arm Multi-Cohort Phase I Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of BCD-100 (JSC BIOCAD, Russia) in Patients With Advanced Solid Tumors
• Actual Study Start Date: August 30, 2016
• Actual Primary Completion Date: July 1, 2017
• Estimated Study Completion Date: November 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: BCD-100 0.3 mg/kg; Patients who receive BCD-100 in a dose of 0.3 mg/kg	Biological: BCD-100; Anti-PD1 monoclonal antibody
Experimental: BCD-100 1 mg/kg; Patients who receive BCD-100 in a dose of 1 mg/kg	Biological: BCD-100; Anti-PD1 monoclonal antibody
Experimental: BCD-100 3 mg/kg; Patients who receive BCD-100 in a dose of 3 mg/kg	Biological: BCD-100; Anti-PD1 monoclonal antibody
Experimental: BCD-100 10 mg/kg; Patients who receive BCD-100 in a dose of 10 mg/kg	Biological: BCD-100; Anti-PD1 monoclonal antibody

Outcome Measures

Primary Outcome Measures :

1. ORR (CR + PR) [ Time Frame: 85 days ]

   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.

   • ORR (CR + PR) after 85 days of therapy with BCD-100.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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 of subsequent therapy lines);
   • Locally advanced or metastatic NSCLC (squamous cell carcinoma/adenocarcinoma), progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);
   • Metastatic clear cell renal carcinoma, progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);

   In addition, by investigator's decision, patients with the following malignancies can also be enrolled in the study :

   • Pleural mesothelioma progressive after at least one therapy line (the drug will be used as a second or subsequent therapy lines);
   • Metastatic bladder cancer progressive after at least one therapy line (the drug will be used as a second or subsequent therapy lines);
   • Triple negative breast cancer (ER-, PR-, HER2-) progressive after at least the first-line therapy (the drug will be used as a second or subsequent therapy lines);
4. ECOG score of 0 to 2;
5. Measurable disease (at least one lesion) according to RECIST v. 1.1 ;
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 12 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-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. Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);
10. Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);
11. Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;
12. Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;
13. Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);
14. 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.
15. Acute infections or active chronic infections;
16. Documented HIV infection;
17. Positive screening results for Hbs-antigen, hepatitis B core antibodies (anti-HBc Ab) and/or hepatitis C antibodies ;
18. Positive results of microprecipitation reaction together with positive TPHA assay results at the screening;
19. Body weight > 95 kg.
20. Intravenous administration of the drug is impossible;
21. Intravenous administration of contrast agents is impossible;
22. Hypersensitivity to any component of BCD-100.
23. Known history of hypersensitivity to monoclonal antibodies;
24. Pregnancy or breastfeeding;

Contacts and Locations

Locations

Russian Federation

"Russian Cancer Research Center named after N.N. Blokhin "of the Ministry of Health of the Russian Federation

Moscow, Russian Federation

LLC BioEk

Saint-Petersburg, Russian Federation

State budgetary health care institution "St. Petersburg Clinical Scientific and Practical Center of Specialized Medical Assistance (Oncological)"

Sankt Petersburg, Russian Federation

N.N.Petrov Oncology Research Center

St.Petersburg, Russian Federation, 197758

Sponsors and Collaborators

Biocad

More Information

• Responsible Party: Biocad
• ClinicalTrials.gov Identifier: NCT03050047
• Other Study ID Numbers: BCD-100-1
• First Posted: February 10, 2017
• Last Update Posted: August 31, 2018
• Last Verified: August 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Carcinoma, Renal Cell; Neoplasms by Histologic Type; Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases