Carcinoma, Non-Small-Cell LungPhase 1NCT04544748
A Phase 1 Study of GNR-051 in Subjects With Advanced Malignancies
A Phase 1 study testing GNR-051 in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Renal Cell, run by AO GENERIUM at 12 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma
- What is being tested?
- GNR-051
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 12 sitesRussia
- Study dates
- 22 Jul 2020to 25 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 33Show fewer
- 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;
- Laboratory parameters:
- Absolute leukocyte count <2000 / μL;
- Absolute neutrophil count <1500 / μL;
- Absolute platelet count <100 × 103 / μL;
- Hemoglobin level <9.0 g / dL;
- Creatinine> 2 mg / dL;
- AST> 2.5 × the upper limit of normal (ULN) in the absence of liver metastases, or> 5 × ULN with the liver metastases;
- ALT > 2.5 × ULN in the absence of liver metastases, or> 5 × ULN with the liver metastases;
- Total bilirubin> 2 × ULN;
- Systemic autoimmune diseases (including but not limited to SLE, Crohn's disease, ulcerative colitis, systemic scleroderma, inflammatory myopathy, mixed connective tissue disease, overlap syndrome, etc.);
- Concomitant cancer (except for basal or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, prostate, or breast);
- Patients who need therapy with corticosteroids or other immunosuppressants;
- Systemic therapy with corticosteroids or immunosuppressants for ≤7 days before the first administration GNR-051;
- Any other concomitant condition (e.g., medical condition, mental disorders, alcohol/drug abuse) that constitutes an unacceptable risk to the patient's health during the investigational therapy or prevents a patient from following the Protocol procedures;
- Active HBV/HCV/HIV infection;
- Pregnant or lactating female;
- Patients with reproductive potential who do not agree to practice acceptable methods of birth control throughout the entire trial period, starting from signing the informed consent and up to 6 months after the last dose of GNR-051;
- Simultaneous participation in other clinical trials.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Russia12 sites
SAHI "Republican Clinical Oncological Dispensary of the Ministry of Health of the Republic of Tatarstan"
Kazan', 420029
FSBI "N.N. Blokhin National Medical Research Center of Oncology"of the Ministry of Health of the Russian Federation
Moscow, 115478
FSBI "Russian Scientific Center of Roentgenoradiology" of the Ministry of Health of the Russian Federation
Moscow, 117997
FSAEI HE "I.M. Sechenov First Moscow State Medical University" of the Ministry of Health of Russian Federation
Moscow, 119991
JSC "MEDSI" Group of Companies"
Moscow, 123056
FSII "Treatment and Rehabilitation Center" of the Ministry of Health of the Russian Federation
Moscow, 125367
FSBI "N.N. Petrov National Medical Research Center of Oncology" of the Ministry of Healthcare of the Russian Federation
Moscow, 197758
SBHI "Leningrad Regional Clinical Oncology Dispensary"
Saint Petersburg, 188663
JSC "Modern Medical Technologies"
Saint Petersburg, 190013
FSAEI HE "I.P. Pavlov First Saint Petersburg State Medical University" of the Ministry of Health of the Russian Federation
Saint Petersburg, 197022
SBHI "St. Petersburg Clinical Scientific and Practical Center for Specialized Types of Medical Care (Oncological)
Saint Petersburg, 197758
LLC "Tentanda Via"
Saint Petersburg, 198035
About this study
Official title: A Multicenter Open-Label Multi-Cohort Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GNR-051 (GENERIUM JSC, Russia) in Subjects With Solid Advanced Malignancies
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.
Read the detailed description
GNR-051 is a monoclonal antibody, targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. The anti-PD-1 antibody, preventing the binding of the PD-1 receptor with the ligands PD-L1 and PD-L2, reactivates the pool of tumor-specific cytotoxic T-lymphocytes in the tumor microenvironment and, thus, reactivates the antitumor immunity. GNR-051 is able to block the signaling molecule PD-1, which suppresses the antitumor immune response, for the treatment of cancer.
- Being tested
- GNR-051
- Keywords
- Neoplasms, Neoplasms by Histologic Type, Adenocarcinoma, Carcinoma, Non-Small-Cell Lung, Melanoma, Carcinoma, Renal Cell, Urologic Neoplasms, Lung Neoplasms, Antineoplastic Agents, Immunological, Kidney Neoplasms
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Carcinoma, Renal Cell, Melanoma, Neoplasms, Neoplasms by Histologic Type, Adenocarcinoma, Urologic Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNR-051Biological
Anti-PD1 monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | GNR-051 (0.1 mg/kg) Receives: Biological: GNR-051 |
| Cohort 2 | Other | GNR-051 (0.3 mg/kg) Receives: Biological: GNR-051 |
| Cohort 3 | Other | GNR-051 (1 mg/kg) Receives: Biological: GNR-051 |
| Cohort 4 | Other | GNR-051 (3 mg/kg) Receives: Biological: GNR-051 |
| Cohort 5 | Other | GNR-051 (10 mg/kg) Receives: Biological: GNR-051 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD)
Tolerability of GNR-051
Measured: 28 Days
Number of participants with dose-limiting toxicity (DLT)
Tolerability of GNR-051
Measured: 28 Days
Laboratory tests
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
Measured: 36 Months
Vital signs
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
Measured: 36 Months
Physical examination
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
Measured: 36 Months
12-lead electrocardiogram
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
Measured: 36 Months
ECOG assessment
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
Measured: 36 Months
Antidrug antibody
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
Measured: 36 Months
Secondary outcomes (26)
GNR-051 Serum Concentration
Pharmacokinetic parameters GNR-051
Measured: 6 Months
Cmax - Maximum serum concentration after the 1st administration
Pharmacokinetic parameters
Measured: 6 Months
Cmin - Minimum serum concentration after the 1st administration
Pharmacokinetic parameters
Measured: 6 Months
Tmax - Time to peak serum concentration after the 1st administration
Pharmacokinetic parameters
Measured: 6 Months
t½ - Half-life after the 1st administration,
Pharmacokinetic parameters
Measured: 6 Months
CL - Clearance after the 1st administration
Pharmacokinetic parameters
Measured: 6 Months
AUC0-t - Area Under the Curve after the 1st administration
Pharmacokinetic parameters
Measured: 6 Months
Tmax, SS - Time to peak serum concentration at steady state
Pharmacokinetic parameters
Measured: 6 Months
CSS - serum concentration at steady state
Pharmacokinetic parameters
Measured: 6 Months
Cmax, SS - Maximum serum concentration at steady state
Pharmacokinetic parameters
Measured: 6 Months
CLSS - Clearance at steady state
Pharmacokinetic parameters
Measured: 6 Months
Cmin, SS - serum concentration at steady state
Pharmacokinetic parameters
Measured: 6 Months
Vd, SS - Volume of distribution at steady state
Pharmacokinetic parameters
Measured: 6 Months
CAUCτ 0-t - Area under the concentration time-curves from zero to the end of the dosing interval at steady state
Pharmacokinetic parameters
Measured: 6 Months
t½,ss - Half-life at steady state
Pharmacokinetic parameters
Measured: 6 Months
AUC0-∞ - Area under the concentration time-curves from time zero to infinity after last administration
PharmacoCkinetic parameters
Measured: 36 Months
Accumulation index (Rac; steady-state AUC0-τ/single-dose AUC0-τ)
Pharmacokinetic parameters
Measured: 6 Months
Time to reach steady state - elimination half-life
Pharmacokinetic parameters
Measured: 6 Months
PD-1 receptor occupancy rate (%) in peripheral blood mononuclear cells (PBMCs)
Pharmacodynamic parameters GNR-051
Measured: 6 Months
Objective Response Rate (ORR)
Objective Response Rate (ORR) - best response of complete remission (CR) or partial remission (PR) according to RECIST 1.1 and IRECIST
Measured: 36 Months
Best objective response rate (complete response (CR) + partial response (PR))
Best objective response rate (complete response (CR) + partial response (PR)) according to RECIST 1.1 and IRECIST
Measured: 36 Months
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) - time from 1st dose administration to progression according to RECIST 1.1 or until death from any cause
Measured: 36 Months
Disease Control Rate (DCR)
Disease Control Rate (DCR) - percentage of patients who have achieved complete response, partial response and stable disease
Measured: 36 Months
Best Overall Response (BOR)
Best Overall Response (BOR) - the best response recorded from the 1st dose administration until the disease progression
Measured: 36 Months
Duration of response (DoR)
Duration of response - the length of time that a tumor continues to respond to treatment without the cancer growing or spreading
Measured: 36 Months
Overall Survival (OS)
Overall Survival (OS) - time from enrollment to the date of death
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start22 Jul 2020
- Primary completion7 Nov 2022
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO GENERIUM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544748
- Sponsor's protocol ID
- APD-SMG-I
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2020
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-Label Multi-Cohort Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of GNR-051 (GENERIUM JSC, Russia) in Subjects With Solid Advanced Malignancies
- ClinicalTrials.gov ID
- NCT04544748
- Acronym / sponsor ID
- APD-SMG-I
- Keywords
- Neoplasms, Neoplasms by Histologic Type, Adenocarcinoma, Carcinoma, Non-Small-Cell Lung, Melanoma, Carcinoma, Renal Cell, Urologic Neoplasms, Lung Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AO GENERIUMIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2020 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
GNR-051 is a monoclonal antibody, targeting the Programmed Death-1 (PD-1) membrane receptor on T lymphocytes and other cells of the immune system. The anti-PD-1 antibody, preventing the binding of the PD-1 receptor with the ligands PD-L1 and PD-L2, reactivates the pool of tumor-specific cytotoxic T-lymphocytes in the tumor microenvironment and, thus, reactivates the antitumor immunity. GNR-051 is able to block the signaling molecule PD-1, which suppresses the antitumor immune response, for the treatment of cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Biological: GNR-051GNR-051 (0.1 mg/kg) |
| Cohort 2 | Other | Biological: GNR-051GNR-051 (0.3 mg/kg) |
| Cohort 3 | Other | Biological: GNR-051GNR-051 (1 mg/kg) |
| Cohort 4 | Other | Biological: GNR-051GNR-051 (3 mg/kg) |
| Cohort 5 | Other | Biological: GNR-051GNR-051 (10 mg/kg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (33 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNR-051Anti-PD1 monoclonal antibody | Biological | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5 |
Primary outcome
Maximum Tolerated Dose (MTD)
Time frame: 28 Days
Tolerability of GNR-051
Number of participants with dose-limiting toxicity (DLT)
Time frame: 28 Days
Tolerability of GNR-051
Laboratory tests
Time frame: 36 Months
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
Vital signs
Time frame: 36 Months
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
Physical examination
Time frame: 36 Months
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
12-lead electrocardiogram
Time frame: 36 Months
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
ECOG assessment
Time frame: 36 Months
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
Antidrug antibody
Time frame: 36 Months
Safety profile of GNR-051; All adverse events (CTCAE 5.0)
26 secondary outcomes
GNR-051 Serum Concentration
Time frame: 6 Months
Cmax - Maximum serum concentration after the 1st administration
Time frame: 6 Months
Cmin - Minimum serum concentration after the 1st administration
Time frame: 6 Months
Tmax - Time to peak serum concentration after the 1st administration
Time frame: 6 Months
t½ - Half-life after the 1st administration,
Time frame: 6 Months
CL - Clearance after the 1st administration
Time frame: 6 Months
AUC0-t - Area Under the Curve after the 1st administration
Time frame: 6 Months
Tmax, SS - Time to peak serum concentration at steady state
Time frame: 6 Months
CSS - serum concentration at steady state
Time frame: 6 Months
Cmax, SS - Maximum serum concentration at steady state
Time frame: 6 Months
CLSS - Clearance at steady state
Time frame: 6 Months
Cmin, SS - serum concentration at steady state
Time frame: 6 Months
Vd, SS - Volume of distribution at steady state
Time frame: 6 Months
CAUCτ 0-t - Area under the concentration time-curves from zero to the end of the dosing interval at steady state
Time frame: 6 Months
t½,ss - Half-life at steady state
Time frame: 6 Months
AUC0-∞ - Area under the concentration time-curves from time zero to infinity after last administration
Time frame: 36 Months
Accumulation index (Rac; steady-state AUC0-τ/single-dose AUC0-τ)
Time frame: 6 Months
Time to reach steady state - elimination half-life
Time frame: 6 Months
PD-1 receptor occupancy rate (%) in peripheral blood mononuclear cells (PBMCs)
Time frame: 6 Months
Objective Response Rate (ORR)
Time frame: 36 Months
Best objective response rate (complete response (CR) + partial response (PR))
Time frame: 36 Months
Progression-Free Survival (PFS)
Time frame: 36 Months
Disease Control Rate (DCR)
Time frame: 36 Months
Best Overall Response (BOR)
Time frame: 36 Months
Duration of response (DoR)
Time frame: 36 Months
Overall Survival (OS)
Time frame: 36 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GNR-051 in people with Carcinoma, Non-Small-Cell Lung and Carcinoma, Renal Cell, run by AO GENERIUM at 12 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) (time frame: 28 Days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.