Advanced cervical cancer
Conditions
Interventions
Becotatug Vedotin treatment group:Becotatug Vedotin treatment
Sponsors
Obstetris & Gynecology Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Females aged >=18 years and =1 cm; 4. Received at least one prior line of standard systemic therapy, which must have included platinum-based agents; 5. Documented EGFR expression (1+, 2+, or 3+) confirmed by immunohistochemistry (IHC); 6. Adequate organ and bone marrow function, with laboratory values meeting the following criteria obtained within 14 days prior to screening: Hemoglobin >9 g/dL without transfusion or erythropoietin administration within 14 days; Absolute neutrophil count (ANC) >=1.5×10^9/L without granulocyte colony-stimulating factor (G-CSF) use within 14 days; Platelet count (PLT) >=9×10^9/L without transfusion within 14 days; Total bilirubin (TBIL) =50 mL/min using the Cockcroft-Gault formula; Adequate coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=1.5×ULN; Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits; subjects with baseline TSH outside normal range may be enrolled if total T3 (or FT3) and free T4 (FT4) are within normal range; Cardiac enzyme profile within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are also permitted); 7. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test within 3 days prior to first study drug administration (Cycle 1 Day 1). If the urine pregnancy test result cannot be confirmed as negative, a serum pregnancy test is required. Non-childbearing potential is defined as postmenopausal status for at least 1 year, surgical sterilization, or hysterectomy; 8. All subjects with reproductive potential must use highly effective contraception (with an annual failure rate <1%) throughout the treatment period and for 120 days after the last dose of study medication; 9. Subjects must agree to provide adequate tumor tissue samples for EGFR and PD-L1 expression testing, including archived tumor samples (paraffin blocks or unstained slides in sufficient quantity for required analyses); if no archived tumor tissue is available, subjects must agree to undergo fresh tumor biopsy.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of any other malignancy within 5 years prior to the first dose, except for adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ with curative resection; 2. Currently participating in an interventional clinical study, or received other investigational drugs or investigational device therapy within 4 weeks prior to the first dose; 3. Received systemic treatment with Traditional Chinese Medicine (TCM) with anti-tumor indications or immunomodulatory agents (including thymosin, interferon, and interleukins, except for local administration to control pleural effusion) within 2 weeks prior to the first dose; 4. Evidence of tumor invasion/infiltration into large blood vessels (great vessels) or bleeding tendency assessed by the investigator or radiologist on imaging; 5. Underwent major surgical procedure (excluding biopsy) within 4 weeks prior to first study drug administration, or planned major surgery during the study period; 6. Severe non-healing wound, ulcer, or fracture; 7. Current or recent (within 10 days prior to first study drug dose) continuous use of aspirin (>325 mg/day) or other nonsteroidal anti-inflammatory drugs (NSAIDs) known to inhibit platelet function for 10 consecutive days; 8. Current or recent (within 10 days prior to first study drug dose) continuous use of full-dose oral or parenteral anticoagulants or thrombolytic agents for 10 consecutive days; Note: Prophylactic use of low-dose anticoagulants is permitted: low-dose warfarin (=2; (3) Any arterial thrombosis, embolism, or ischemia within 6 months prior to enrollment, such as myo
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival (OS);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactJingxin Ding
Obstetris & Gynecology Hospital of Fudan University
Outcome results
None listed