a phase ⅱ study of f520 in patients with cervical carcinoma

Conditions: Cervical Cancer

Summary: this study was an open, single-arm, enriched, multicenter phase ii study.

the trial was divided into screening period, treatment period and follow-up period. participants entered the screening period after signing informed consent and met the inclusion criteria. subjects who did not meet the exclusion criteria were treated with f520 monotherapy, intravenously, at 3mg/kg every 3 weeks until disease progression or intolerable toxicity or withdrawal for other reasons, for a maximum of 2 years.

Eligibility criteria:
inclusion criteria: 1. women aged 18 years and above; 2. cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma confirmed by histopathology; 3. patients with advanced (stage ivb) cervical cancer that is inoperable and/or radiotherapy-resistant, or patients with persistent, recurrent or metastatic cervical cancer that progresses after first-line or above chemotherapy; 4. according to recist1.1 criteria, subjects must have at least one measurable target lesion examined by enhanced ct and/or enhanced mri (non-lymph node diameter ≥10mm, or lymph node lesion diameter ≥15mm); 5. expected survival ≥3 months; 6. those with 0-2 scores on the american eastern oncology collaboration group (ecog) scale; 7. those who agree to provide archived tumor tissue samples or fresh tissue samples; 8. the function of vital organs meets the following requirements (drugs with blood components and cell growth factors are not allowed to be used within 14 days before the first administration) : blood routine: absolute neutrophil count ≥1.5×109/l; platelet ≥75×109/l; hemoglobin ≥90g/l; liver function: tbil≤1.5×uln, alt and ast≤2.5×uln; if liver metastasis was present, tbil≤3×uln, alt and ast≤5×uln; renal function: serum creatinine (cr) ≤1.5×uln; thyroid stimulating hormone (tsh) in the normal range; if tsh is abnormal, free triiodothyronine (ft3) and free thyroxine (ft4) must be normal or abnormal without clinical significance. international normalized ratio (inr) ≤1.5×uln and activated partial thromboplastin time (aptt) ≤1.5×uln. exclusion criteria: 1. patients with specific pre-existing conditions such as active autoimmune disease, type 1 diabetes, hypothyroidism requiring hormone replacement, and severe mental illness; 2. a history of other malignancies within the last 3 years, except locally curable cancers (limited to basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the breast); 3. patients with central nervous system metastasis with clinical symptoms; 4. previously treated with anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-ctla-4 antibodies or any other antibody or drug targeting t-cell co-stimulation or immune checkpoint pathways; 5. immunosuppressive, systemic or local hormone therapy within 14 days prior to initial administration for immunosuppressive purposes (daily dose equivalent to prednisone \&gt; 10mg of systemic corticosteroid); 6. active infection requiring systemic treatment or unexplained fever during screening or prior to initial dosing \&gt; 38.5℃ (according to the investigators' judgment, patients with fever caused by tumors could be included in the group); 7. patients receiving systemic tumor therapy with radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy or antibody drugs within 4 weeks before the first dose; those who had been treated with monoclonal antibody coupled radionuclides or cytotoxins within 10 weeks prior to initial administration; the toxicity of previous anti-tumor therapy did not return to ≤ grade 1 (except hair loss); 8. those who have had previous organ transplantation or received autologous stem cell transplantation within 3 months before the first administration; 9. infected with active tuberculosis; 10. suffering from interstitial lung disease (except for interstitial lung disease caused by radiotherapy and chemotherapy and currently asymptomatic); 11. active hepatitis; 12. hiv antibody positive; 13. have been treated with any other investigational drug/device within 4 weeks prior to initial dosing; 14. have uncontrolled or severe cardiovascular disease, such as new york heart association (nyha) class ii or above congestive heart failure, unstable angina, myocardial infarction and other cardiovascular disease within 6 months before the first dose; difficult to control hypertension (systolic blood pressure ≥180mmhg and/or diastolic blood pressure ≥100mmhg); 15. those who have a history of drug abuse or alcoholism within 6 months before the first dose; 16. known patients with previous macromolecular protein preparations, or known anti-pd-1 /pd-l1 antibodies; 17. those who received live attenuated vaccine within 4 weeks prior to the first dose (except inactivated influenza vaccines such as injectable seasonal influenza vaccine); 18. pregnant or lactating women, women who planned to become pregnant during the study period and within 6 months after the last dose, and who did not wish to use a medically approved effective contraceptive method (such as an iud or condom) during the trial period; 19. those who were judged not suitable for inclusion by the researchers.