A Phase Ⅱ Study of F520 in Patients With Cervical Carcinoma

NCT06226350 | Completed Phase 2

• 1 other identifier: NTP-F520-005
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study was an open, single-arm, enriched, multicenter Phase II study.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Objective tumor response rate (ORR) assessed by RECIST1.1

  CR+PR

  approximately 2 years

Study Arms (1)

F520 monotherapy

EXPERIMENTAL

Drug: Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection

Interventions

Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection DRUG

F520,IV, 3mg/kg every 3 weeks, for up to 2 years until disease progression, intolerable toxic reactions, or termination of treatment for other reasons.

F520 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years and above;
• Cervical squamous cell carcinoma, adenosquamous cell carcinoma or adenocarcinoma confirmed by histopathology;
• 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;
• 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);
• Expected survival ≥3 months;
• Those with 0-2 scores on the American Eastern Oncology Collaboration Group (ECOG) scale;
• Those who agree to provide archived tumor tissue samples or fresh tissue samples;
• 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.

You may not qualify if:

• Patients with specific pre-existing conditions such as active autoimmune disease, type 1 diabetes, hypothyroidism requiring hormone replacement, and severe mental illness;
• 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);
• Patients with central nervous system metastasis with clinical symptoms;
• 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;
• 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);
• 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);
• 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);
• Those who have had previous organ transplantation or received autologous stem cell transplantation within 3 months before the first administration;
• infected with active tuberculosis;
• suffering from interstitial lung disease (except for interstitial lung disease caused by radiotherapy and chemotherapy and currently asymptomatic);
• Active hepatitis;
• HIV antibody positive;
• have been treated with any other investigational drug/device within 4 weeks prior to initial dosing;
• 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);
• Those who have a history of drug abuse or alcoholism within 6 months before the first dose;

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Shandong New Time Pharmaceutical Co., LTD

Shandong, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• QI ZHOU, MD

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: March 4, 2021
• Primary Completion: December 5, 2023
• Study Completion: January 3, 2024
• Last Updated: January 26, 2024

Record last verified: 2024-01

Locations

CN (1)