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

NCT03050047 | Unknown Phase 1

• 1 other identifier: BCD-100-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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

Conditions

Melanoma; Lung Cancer; Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• ORR (CR + PR)

  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.

  85 days

Study Arms (4)

BCD-100 0.3 mg/kg

EXPERIMENTAL

Patients who receive BCD-100 in a dose of 0.3 mg/kg

Biological: BCD-100

BCD-100 1 mg/kg

EXPERIMENTAL

Patients who receive BCD-100 in a dose of 1 mg/kg

Biological: BCD-100

BCD-100 3 mg/kg

EXPERIMENTAL

Patients who receive BCD-100 in a dose of 3 mg/kg

Biological: BCD-100

BCD-100 10 mg/kg

EXPERIMENTAL

Patients who receive BCD-100 in a dose of 10 mg/kg

Biological: BCD-100

Interventions

BCD-100 BIOLOGICAL

Anti-PD1 monoclonal antibody

BCD-100 0.3 mg/kg; BCD-100 1 mg/kg; BCD-100 10 mg/kg; BCD-100 3 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient provides a written informed consent and is able to follow the requirements of the Protocol;
• Age ≥ 18 years
• 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);
• ECOG score of 0 to 2;
• Measurable disease (at least one lesion) according to RECIST v. 1.1 ;
• 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);
• No severe pathology of organs or systems;
• Life expectancy of at least 12 weeks from the screening;

You may not qualify if:

• Severe concomitant illnesses or life-threatening consequences (including pleural/pericardial/peritoneal effusion that requires medical intervention , pulmonary lymphangitis, or involvement of \>50% renal parenchyma);
• Severe cardiovascular disorders within 6 months before screening;
• Autoimmune diseases;
• Conditions requiring steroids or any other immunosuppressants;
• Blood disorders: ANC ≤1,500/mm3; platelets ≤100,000/mm3; or Hb ≤90 g/L;
• Renal function impairment: creatinine ≥1.5 × ULN;
• Hepatic function impairment: bilirubin ≥1.5 × ULN; AST and ALT ≥2.5 × ULN (5 × ULN for patients with liver metastases), AlkPh ≥ 5 × ULN;
• Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy , or chemotherapy);
• Known history of more than 6 lines of systemic anticancer chemotherapy (including neoadjuvant and adjuvant CTs);
• Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;
• Concurrent malignancy except for radically resected cervical carcinoma in situ or radically resected basal cell/squamous cell carcinoma;
• Conditions limiting patient's ability to follow the Protocol requirements (dementia, neurological or psychiatric disorders, drug or alcohol abuse, etc.);
• Acute infections or active chronic infections;
• Documented HIV infection;
• Positive screening results for Hbs-antigen, hepatitis B core antibodies (anti-HBc Ab) and/or hepatitis C antibodies ;

Sponsors & Collaborators

• Biocad: lead

Study Sites (4)

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

Moscow, Russia

Location

N.N.Petrov Oncology Research Center

Saint Petersburg, 197758, Russia

Location

LLC BioEk

Saint Petersburg, Russia

Location

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

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Melanoma; Lung Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: August 30, 2016
• Primary Completion: July 1, 2017
• Study Completion: November 1, 2018
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

RU (4)