Phase â… Study to Evaluate the Safety and Tolerability of Using F520 (NCT03657381) | Clinical Trial Compass
UnknownPhase 1
Phase â… Study to Evaluate the Safety and Tolerability of Using F520
China75 participantsStarted 2019-03-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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)；
✓. 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）:
✓. Thyroid function indicators: thyroid-stimulating hormone (TSH) and free thyroxine (FT3/FT4) are within the normal range;
Exclusion criteria
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
. 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 syndromeï¼›
✕. 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；
✕. 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;