Search / Trial NCT06226350

A Phase Ⅱ Study of F520 in Patients With Cervical Carcinoma

Launched by SHANDONG NEW TIME PHARMACEUTICAL CO., LTD · Jan 17, 2024

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Trial Information

Current as of October 09, 2024

Completed

Keywords

Description

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.

Gender

FEMALE

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 \> 10mg of systemic corticosteroid);
  • 6. Active infection requiring systemic treatment or unexplained fever during screening or prior to initial dosing \> 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.

About Shandong New Time Pharmaceutical Co., Ltd

Shandong New Time Pharmaceutical Co., Ltd. is a leading biopharmaceutical company based in China, dedicated to the research, development, and commercialization of innovative therapies. With a strong focus on enhancing patient outcomes, the company specializes in a diverse range of pharmaceutical products, including biologics, small molecules, and generics. Committed to maintaining the highest standards of quality and regulatory compliance, Shandong New Time collaborates with global partners to advance clinical trials and bring novel treatments to market. Their mission is to contribute to the improvement of global health through cutting-edge research and development initiatives.

Locations

Shandong, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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