NCT04544748

Brief Summary

It is a Phase 1 Multicenter Open-Label Multi-Cohort Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GNR-051 in Subjects with Advanced Solid Malignancies.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2020

Longer than P75 for phase_1

Geographic Reach
1 country

12 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 10, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2022

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

2.3 years

First QC Date

August 31, 2020

Last Update Submit

March 5, 2024

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, Renal CellMelanoma

Keywords

NeoplasmsNeoplasms by Histologic TypeAdenocarcinomaCarcinoma, Non-Small-Cell LungMelanomaCarcinoma, Renal CellUrologic NeoplasmsLung NeoplasmsAntineoplastic Agents, ImmunologicalKidney Neoplasms

Outcome Measures

Primary Outcomes (8)

  • Maximum Tolerated Dose (MTD)

    Tolerability of GNR-051

    28 Days

  • Number of participants with dose-limiting toxicity (DLT)

    Tolerability of GNR-051

    28 Days

  • Laboratory tests

    Safety profile of GNR-051; All adverse events (CTCAE 5.0)

    36 Months

  • Vital signs

    Safety profile of GNR-051; All adverse events (CTCAE 5.0)

    36 Months

  • Physical examination

    Safety profile of GNR-051; All adverse events (CTCAE 5.0)

    36 Months

  • 12-lead electrocardiogram

    Safety profile of GNR-051; All adverse events (CTCAE 5.0)

    36 Months

  • ECOG assessment

    Safety profile of GNR-051; All adverse events (CTCAE 5.0)

    36 Months

  • Antidrug antibody

    Safety profile of GNR-051; All adverse events (CTCAE 5.0)

    36 Months

Secondary Outcomes (26)

  • GNR-051 Serum Concentration

    6 Months

  • Cmax - Maximum serum concentration after the 1st administration

    6 Months

  • Cmin - Minimum serum concentration after the 1st administration

    6 Months

  • Tmax - Time to peak serum concentration after the 1st administration

    6 Months

  • t½ - Half-life after the 1st administration,

    6 Months

  • +21 more secondary outcomes

Study Arms (5)

Cohort 1

OTHER

GNR-051 (0.1 mg/kg)

Biological: GNR-051

Cohort 2

OTHER

GNR-051 (0.3 mg/kg)

Biological: GNR-051

Cohort 3

OTHER

GNR-051 (1 mg/kg)

Biological: GNR-051

Cohort 4

OTHER

GNR-051 (3 mg/kg)

Biological: GNR-051

Cohort 5

OTHER

GNR-051 (10 mg/kg)

Biological: GNR-051

Interventions

GNR-051BIOLOGICAL

Anti-PD1 monoclonal antibody

Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed Informed Consent Form and the subject's ability to follow the Protocol requirements;
  • Age: 18 years and older at the signing of the informed consent;
  • Histologically confirmed metastatic solid malignant tumors (non-small cell lung cancer, renal cell carcinoma, melanoma), refractory or recurrent after one or more courses of previous therapy and not subject to surgical treatment and radiation therapy. Melanoma - regardless of the presence and success of previous treatment;
  • ECOG performance status ≤ 2;
  • At least one RESICT 1.1-defined measurable target lesion;
  • Completion of the previous drug treatment of the underlying disease (if applicable) at least 28 days before the first administration of GNR-051;
  • Resolution or stabilization of toxicity manifestations of previous radiation or chemotherapy.

You may not qualify if:

  • Prior treatment with anti-CTLA4 and/or anti-PD-1/PD-L1/PD-L2 agents;
  • Hypersensitivity to any of the components of GNR-051;
  • Progression (growth of previous, appearance of new) metastases in the brain and meninges, identified by CT or MRI, in a period of less than 56 days before the first administration of GNR-051; worsening of neurological symptoms in a patient with metastases in the brain or meninges within a period of less than 28 days before the first administration of GNR-051; or continued treatment of metastases in the brain or meninges with glucocorticosteroids (GCS) for a period of less than 14 days before the first administration of GNR-051 (except for a maintenance daily dose of GCS equivalent to 10 mg of prednisolone);
  • Inability to conduct a biopsy according to the protocol;
  • Left ventricular ejection fraction (LVEF) \<50% (EchoCG);
  • The need to use anticancer drugs, other than the investigated one, for at least 3 months after the first administration of the drug;
  • Patients who need radiotherapy or surgical therapy;
  • Previous radiotherapy ended \<28 days before the first dose administration;
  • Previous stereotactic radiation therapy ended \<14 days before the first dose administration;
  • Therapeutic use of radiopharmaceuticals ≤56 days prior to first dose administration;
  • Patients who have received another experimental drug (not registered in Russia) within 28 days or 5 half-lives of the experimental drug before the first administration GNR-051;
  • Patients who have received vaccines against infectious diseases (eg influenza virus) within 28 days before the first administration of the drug;
  • Patients who have received narcotic analgesics \<14 days before the first administration of GNR-051;
  • Surgery with general anesthesia \<28 days before the first administration of GNR-051.
  • Surgery with regional / epidural anesthesia \<72 hours and / or not all post-anesthetic AEs resolved before the first administration of GNR-051;
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

SAHI "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan"

Kazan', 420029, Russia

Location

FSBI "N.N. Blokhin National Medical Research Center of Oncology"of the Ministry of Health of the Russian Federation

Moscow, 115478, Russia

Location

FSBI "Russian Scientific Center of Roentgenoradiology" of the Ministry of Health of the Russian Federation

Moscow, 117997, Russia

Location

FSAEI HE "I.M. Sechenov First Moscow State Medical University" of the Ministry of Health of Russian Federation

Moscow, 119991, Russia

Location

JSC "MEDSI" Group of Companies"

Moscow, 123056, Russia

Location

FSII "Treatment and Rehabilitation Center" of the Ministry of Health of the Russian Federation

Moscow, 125367, Russia

Location

FSBI "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Healthcare of the Russian Federation

Moscow, 197758, Russia

Location

SBHI "Leningrad Regional Clinical Oncology Dispensary"

Saint Petersburg, 188663, Russia

Location

JSC "Modern Medical Technologies"

Saint Petersburg, 190013, Russia

Location

FSAEI HE "I.P. Pavlov First Saint Petersburg State Medical University" of the Ministry of Health of the Russian Federation

Saint Petersburg, 197022, Russia

Location

SBHI "St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)

Saint Petersburg, 197758, Russia

Location

LLC "Tentanda Via"

Saint Petersburg, 198035, Russia

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCarcinoma, Renal CellMelanomaNeoplasmsNeoplasms by Histologic TypeAdenocarcinomaUrologic NeoplasmsLung NeoplasmsKidney Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesCarcinomaNeoplasms, Glandular and EpithelialUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue 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

August 31, 2020

First Posted

September 10, 2020

Study Start

July 22, 2020

Primary Completion

November 7, 2022

Study Completion

January 1, 2025

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

RU(12)