Phase I Study of BCD-145 (Anti-CTLA-4) in Patients With Unresectable/Metastatic Melanoma

NCT03472027 | Completed Phase 1 DMC

• 1 other identifier: BCD-145-1
• 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-145 (JSC BIOCAD, Russia) Monotherapy in Patients with Unresectable/Metastatic Melanoma.

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

• Number of participants with Dose-Limiting Toxicities (DLTs)

  The Investigators defined Dose-Limiting Toxicities (DLTs) as * any treatment-related adverse events of grade 3 or greater, * grade 3 or greater immune-mediated toxic effects (defined as an inflammatory process that compromised the function of any organ and was not attributable to another cause) that had the potential to be life threatening with continuation of therapy, * immune-mediated toxic effects that did not resolve or improved to grade 2 or less within 14 days of onset

  85 days

Secondary Outcomes (2)

• Anti-Drug Antibody levels of BCD-145

  85 days

• Number of Participants With Objective Response

  85 days

Study Arms (5)

BCD-145 Monotherapy Dose Level 1

EXPERIMENTAL

Biological: BCD-145

BCD-145 Monotherapy Dose Level 2

EXPERIMENTAL

Biological: BCD-145

BCD-145 Monotherapy Dose Level 3

EXPERIMENTAL

Biological: BCD-145

BCD-145 Monotherapy Dose Level 4

EXPERIMENTAL

Biological: BCD-145

BCD-145 Monotherapy Dose Level 5

EXPERIMENTAL

Biological: BCD-145

Interventions

BCD-145 BIOLOGICAL

Anti-CTLA-4 monoclonal antibody, IV infusion

BCD-145 Monotherapy Dose Level 1; BCD-145 Monotherapy Dose Level 2; BCD-145 Monotherapy Dose Level 3; BCD-145 Monotherapy Dose Level 4; BCD-145 Monotherapy Dose Level 5

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 (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);
• ECOG score of 0 to 2;
• Measurable disease (at least one lesion) according to RECIST v1.1 ;
• 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 16 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);
• Brain metastases ;
• 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;
• Endocrine disorders: abnormal thyroid hormones
• 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;

Sponsors & Collaborators

• Biocad: lead

Study Sites (4)

N.N. Blokhin National Medical Research Center of Oncology

Moscow, 115478, Russia

Location

JSC "Modern Medical Technologies"

Saint Petersburg, 190013, Russia

Location

N.N. Petrov National Medical Research Center of Oncology

Saint Petersburg, 197758, Russia

Location

Saint-Petersburg Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

Saint Petersburg, 197758, Russia

Location

MeSH Terms

Conditions

Melanoma

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

Study Officials

• Roman A Ivanov, PhD

  Vice President R&D, JSC BIOCAD

  STUDY DIRECTOR

Study Design

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

Model Details: 3+3 dose escalation

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 21, 2018
• Study Start: October 2, 2017
• Primary Completion: September 11, 2018
• Study Completion: December 4, 2018
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (4)