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

NCT03464032 | Unknown Phase 1 DMC

• 1 other identifier: BCD-135-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Melanoma; NSCLC; Renal Cell Carcinoma; Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• DCR

  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

Study Arms (1)

BCD-135

EXPERIMENTAL

Dose-escalation Arm (0.4, 1, 3, 10, 20 mg/kg)

Drug: BCD-135

Interventions

BCD-135 DRUG

Monoclonal anti-PD-L1 antibody

BCD-135

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 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);
• ECOG score of 0 to 1;
• 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
• Measurable disease (at least one lesion) according to RECISTv.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;
• LDH level \>2 ULN;
• Prior anticancer treatment within 28 days before starting the study drug (surgery, radiation therapy, targeted therapy, immunotherapy, vaccine treatment or chemotherapy);
• More than
• therapy lines of unresectable/metastatic melanoma,
• therapy line of metastatic NSCLC,
• therapy lines of metastatic RCC;
• therapy line of metastatic BC;
• Prior treatment with anti-PD1/PDL1 agents or CTLA4 inhibitors;

Sponsors & Collaborators

• Biocad: lead

Study Sites (1)

LLC BioEk

Saint Petersburg, Russia

RECRUITING

MeSH Terms

Conditions

Melanoma; Carcinoma, Renal Cell; Urinary Bladder Neoplasms

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; 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; Urinary Bladder Diseases

Study Officials

• Svetlana Odintsova, MD

  LLC BioEk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariia Shustova, MD

CONTACT

+7 (812) 380 49 33; shustova@biocad.ru

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 13, 2018
• Study Start: October 31, 2017
• Primary Completion: May 31, 2018
• Study Completion: October 31, 2018
• Last Updated: March 13, 2018

Record last verified: 2018-03

Locations

RU (1)