Advanced Solid Tumor，Recurrent Solid Tumor，Lymphoma，Recurrent Lymphocyte Depleted Classical Hodgkin LymphomaPhase 1NCT03657381

Phase Ⅰ Study to Evaluate the Safety and Tolerability of Using F520

A Phase 1 study testing Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection in people with Advanced Solid Tumor，Recurrent Solid Tumor，Lymphoma，Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumor，Recurrent Solid Tumor，Lymphoma，Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma
What is being tested?: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteChina
Study dates: 1 Mar 2019to 8 Oct 2022
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

Male or female 18-65 years of age;
Histologically or cell confirmed advanced, unresectable or metastatic disease tumor and failure to standard therapies or lack of standard therapy(disease progress or failed to tolerate the toxicity, such as chemotherapy, targeted therapy, and other immunotherapies other than PD-1/PD-L1);
Agree to provide archived tumor tissue specimens or fresh tissue specimens;
ECOG performance status of 0 or 1;
Life expectancy ≥ 12 weeks.;
At least one measurable and evaluable tumor lesion (in accordance with international working group criteria/RANO/cheson 2007)；

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Adequate laboratory parameters during the screening period as evidenced by the following（No blood components and cell growth factors are allowed within 28 days prior to screening）:
routine blood tests: Absolute neutrophil count ≥1.0×109/L ;Platelets ≥100×109/L;Hemoglobin ≥ 9.0 g/dL; Liver function：Total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), ALT and AST ≤2.5ULN; for subjects with liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5×ULN, Total bilirubin (TBIL) ≤3×upper limit of normal (ULN); Renal function CCr≤1.5×ULN，Creatinine clearance≥50 mL/min;
Thyroid function indicators: thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are within the normal range;
Understand study procedures and contents, and voluntarily sign the written informed consent form.

Who cannot join

Subjects with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: Immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue disease, scleroderma, inflammatory bowel disease including Crowe Enthusiasm and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis or Stevens-Johnson syndrome；
Presence of symptomatic central nervous system (CNS) metastases；
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 14 days before entering the group and during the study period;
Prior radiotherapy, systemic chemotherapy hormone therapy, surgery or target therapy within 4 weeks or 5 half-lives(whichever is longer) before the study drug administration, or any unresolved AEs > CTC-AE Grade 1;
Autologous hematopoietic stem cell transplantation (ASCT) has been completed at least 3 months before receiveing first dose;
Known history of hypersensitivity to macromolecular protein preparation or any components of the F520 formulation；

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Patients receiving any anti-infection vaccine within 4 weeks before enrollment;
History or concurrent with other malignant disease, except completely cured basal cell skin cancers and carcinoma in situs of cervix;
Uncontrolled clinically significant heart disease, including but not limited to the following: (1) >2 NYHA 2 congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
Active infection（needing therapy） or an unexplained fever > 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
Patients with active pulmonary tuberculosis; patients who previously had active pulmonary tuberculosis;
History of immunodeficiency (HIV) or active hepatitis(Hepatitis B: HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc,HBV-DNA; Hepatitis C: Anti-HCV,HCV-RNA)
Participation in a clinical study or less than 1 month from the last dose of investigational drug to sign ICF;
History of PD-1/PD-L1 or CTLA-4 therapy;
Patients with drug abuse history or alcohol addiction history;
Patients with current or previous interstitial lung diseases;
Female and male who have reproductive potential must be willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy while on treatment and for at least 6 months after receiving the last dose of study treatment.
Other factors that may lead to the termination of the participation in the study at the discretion of the investigators.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

Shaohong Yin
Linyi, Shandong, 276006
Shaohong Yin, 86-15265901803, yinshaohong@lunan.com.cn
Recruiting

Other trials in China

About this study

Official title: Phase Ⅰ Study to Evaluate the Safety and Tolerability of Using F520 by Advanced Tumor Subjects

Recombinant Programmed death-1(PD-1) humanized monoclonal antibody injection (company code: F520) is joint developed by Shandong New Time Pharmaceutical Co., LTD., it is the reorganization of deoxyribonucleic acid (DNA) technology in the Chinese hamster ovary (CHO) cells express system expressed in a immunoglobulin G1 (IgG1) kappa type single resistance to predominate. F520 had the different new amino acid sequence and molecular structure compared with two marketed PD-1 monoclonal antibody injection and got the approval of China Food and Drug Administration (CFDA) for clinical trial.Pharmaceutical research indicated F520 cell strain had security source, production process is stable, quality can control, preparation stability, has good compatibility with packaging materials, it has the condition of industrialization, can prepare investigational medicinal product with safety, effective, and controlled quality for clinical research.Pharmacodynamics study show the targets and mechanisms of F520is clear, tumor suppression effect is obvious.Toxicology studies show this product in high doses with low toxic, and the toxic is reversible, the most common toxicity is specific to the drug action mechanism.

Conditions: Advanced Solid Tumor，Recurrent Solid Tumor，Lymphoma，Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma
Being tested: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionDrug
Biological: F520 single-dose:0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 200mg/times, 10mg/kg; multiple dosing: 1mg/kg, 3mg/kg, 200mg/times, 10mg/kg, treat every 2 weeks; multiple dosing: 3mg/kg, 200mg/times, treat every 3 weeks.

Study groups in NCT03657381
Study group	Role	What they receive
F520 0.2mg/kg single-dose	Experimental	F520 0.2mg/kg single-dose Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 1.0mg/kg single-dose	Experimental	F520 1.0mg/kg single-dose Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 3.0mg/kg single-dose	Experimental	F520 3.0mg/kg single-dose Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 200mg/times single-dose	Experimental	F520 200mg/times single-dose Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 10mg/kg single-dose	Experimental	F520 10mg/kg single-dose Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 1mg/kg multiple dosing, every 2 weeks	Experimental	F520 1mg/kg every 2 weeks Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 3mg/kg multiple dosing, every 2 weeks	Experimental	F520 3mg/kg every 2 weeks Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 200mg/times multiple dosing, every 2 weeks	Experimental	F520 200mg/times every 2 weeks Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 10mg/kg multiple dosing, every 2 weeks	Experimental	F520 10mg/kg every 2 weeks Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 3mg/kg multiple dosing, every 3 weeks	Experimental	F520 3mg/kg every 3 weeks Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection
F520 200mg/times multiple dosing, every 3 weeks	Experimental	F520 200mg/times every 3 weeks Receives: Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: 1.5 years

Secondary outcomes (13)

PD-1 receptor occupancy of blood
Measured: 3 years
Objective Response Rate (ORR) by irRC/ RECIST 1.1/RANO/cheson2007
Measured: 3 years
Disease Control Rate (DCR) by irRC/ RECIST 1.1/RANO/cheson2007
Measured: 3 years
Maximum Plasma Concentration (Cmax) after single dose injection of Anti-PD-1 Monoclonal Antibody (mAb)
Measured: 1.5years
Peak Time (Tmax) after single dose injection of Anti-PD-1 mAb
Measured: 1.5years
Area Under the Curve (AUC) after single dose injection of Anti-PD-1 mAb
Measured: 1.5years
t1/2 after single dose injection of Recombinant Humanized Anti-PD-1 mAb
Measured: 1.5years
Plasma clearance (CL) after single dose injection of Anti-PD-1 mAb
Measured: 1.5years
Apparent volume of distribution (V) after single dose injection of Anti-PD-1 mAb
Measured: 1.5years
Minimum Plasma Concentration (Cmin) of steady state after multiple dose injection of Anti-PD-1 mAb
Measured: 1.5years
Average Plasma Concentration (Cavg) of steady state after multiple dose injection of Anti-PD-1 mAb
Measured: 1.5years
degree of fluctuation (DF) of steady state after multiple dose injection of Anti-PD-1 mAb
Measured: 1.5years
Apparent volume of distribution of steady state (Vss) after multiple dose injection of Anti-PD-1 mAb
Measured: 1.5years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20198 Oct 2022

First posted5 Sep 2018
Study start1 Mar 2019
Primary completion8 Feb 2021 (estimated)
Study completion8 Oct 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced Solid Tumor，Recurrent Solid Tumor，Lymphoma，Recurrent Lymphocyte Depleted Classical Hodgkin LymphomaStudies 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: Single group
Masking: None (open label)
Enrolment: 75 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03657381
Sponsor's protocol ID: NTP-F520-001
Status last verified: Oct 2020
First submitted: 31 Aug 2018
Last updated: 22 Oct 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase Ⅰ Study to Evaluate the Safety and Tolerability of Using F520 by Advanced Tumor Subjects
ClinicalTrials.gov ID: NCT03657381
Acronym / sponsor ID: NTP-F520-001
Conditions: Advanced Solid Tumor，Recurrent Solid Tumor，Lymphoma，Recurrent Lymphocyte Depleted Classical Hodgkin Lymphoma
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 75 participants (estimated)
Lead sponsor: Shandong New Time Pharmaceutical Co., LTDIndustry (pharma, biotech, devices)
Study start: 1 Mar 2019 (actual)
Primary completion: 8 Feb 2021 (estimated)
Study completion: 8 Oct 2022 (estimated)
First posted: 5 Sep 2018 (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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 11

Arm	Type	Receives
F520 0.2mg/kg single-dose	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 0.2mg/kg single-dose
F520 1.0mg/kg single-dose	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 1.0mg/kg single-dose
F520 3.0mg/kg single-dose	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 3.0mg/kg single-dose
F520 200mg/times single-dose	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 200mg/times single-dose
F520 10mg/kg single-dose	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 10mg/kg single-dose
F520 1mg/kg multiple dosing, every 2 weeks	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 1mg/kg every 2 weeks
F520 3mg/kg multiple dosing, every 2 weeks	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 3mg/kg every 2 weeks
F520 200mg/times multiple dosing, every 2 weeks	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 200mg/times every 2 weeks
F520 10mg/kg multiple dosing, every 2 weeks	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 10mg/kg every 2 weeks
F520 3mg/kg multiple dosing, every 3 weeks	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 3mg/kg every 3 weeks
F520 200mg/times multiple dosing, every 3 weeks	Experimental	Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionF520 200mg/times every 3 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male or female 18-65 years of age;
Histologically or cell confirmed advanced, unresectable or metastatic disease tumor and failure to standard therapies or lack of standard therapy(disease progress or failed to tolerate the toxicity, such as chemotherapy, targeted therapy, and other immunotherapies other than PD-1/PD-L1);
Agree to provide archived tumor tissue specimens or fresh tissue specimens;
ECOG performance status of 0 or 1;
Life expectancy ≥ 12 weeks.;

Key exclusion criteria (18 listed)

Subjects with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: Immune-related neurological diseases, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue disease, scleroderma, inflammatory bowel disease including Crowe Enthusiasm and ulcerative colitis, autoimmune hepatitis, toxic epidermal necrolysis or Stevens-Johnson syndrome；
Presence of symptomatic central nervous system (CNS) metastases；
Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses > 10 mg/day prednisone or equivalent are prohibited within 14 days before entering the group and during the study period;
Prior radiotherapy, systemic chemotherapy hormone therapy, surgery or target therapy within 4 weeks or 5 half-lives(whichever is longer) before the study drug administration, or any unresolved AEs > CTC-AE Grade 1;
Autologous hematopoietic stem cell transplantation (ASCT) has been completed at least 3 months before receiveing first dose;

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
Recombinant Humanized Anti-PD-1 Monoclonal Antibody InjectionBiological: F520 single-dose:0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 200mg/times, 10mg/kg; multiple dosing: 1mg/kg, 3mg/kg, 200mg/times, 10mg/kg, treat every 2 weeks; multiple dosing: 3mg/kg, 200mg/times, treat every 3 weeks.	Drug	F520 0.2mg/kg single-dose, F520 1.0mg/kg single-dose, F520 10mg/kg multiple dosing, every 2 weeks, F520 10mg/kg single-dose, F520 1mg/kg multiple dosing, every 2 weeks, F520 200mg/times multiple dosing, every 2 weeks, F520 200mg/times multiple dosing, every 3 weeks, F520 200mg/times single-dose, F520 3.0mg/kg single-dose, F520 3mg/kg multiple dosing, every 2 weeks, F520 3mg/kg multiple dosing, every 3 weeks

Primary outcome

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: 1.5 years

13 secondary outcomes

PD-1 receptor occupancy of blood
Time frame: 3 years
Objective Response Rate (ORR) by irRC/ RECIST 1.1/RANO/cheson2007
Time frame: 3 years
Disease Control Rate (DCR) by irRC/ RECIST 1.1/RANO/cheson2007
Time frame: 3 years
Maximum Plasma Concentration (Cmax) after single dose injection of Anti-PD-1 Monoclonal Antibody (mAb)
Time frame: 1.5years
Peak Time (Tmax) after single dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Area Under the Curve (AUC) after single dose injection of Anti-PD-1 mAb
Time frame: 1.5years
t1/2 after single dose injection of Recombinant Humanized Anti-PD-1 mAb
Time frame: 1.5years
Plasma clearance (CL) after single dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Apparent volume of distribution (V) after single dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Minimum Plasma Concentration (Cmin) of steady state after multiple dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Average Plasma Concentration (Cavg) of steady state after multiple dose injection of Anti-PD-1 mAb
Time frame: 1.5years
degree of fluctuation (DF) of steady state after multiple dose injection of Anti-PD-1 mAb
Time frame: 1.5years
Apparent volume of distribution of steady state (Vss) after multiple dose injection of Anti-PD-1 mAb
Time frame: 1.5years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.

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.

Shaohong Yin

Linyi, China

86-15265901803

yinshaohong@lunan.com.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. (time frame: 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03657381.

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 22 Oct 2020.