This is a prospective, multicenter, single-arm clinical trial investigating Becotatug Vedotin in combination with Zimberelimab for the treatment of patients with recurrent and metastatic cervical cancer, vulvar cancer, and vaginal cancer. A total of 30 patients are expected to be enrolled. The study consists of a screening period (within 28 days), a treatment period, and a follow-up period (safety follow-up and survival follow-up). Trial treatment will continue until the patient has received Becotatug Vedotin for 1 year, or until disease progression, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first.
Subjects will sign the informed consent form and undergo baseline examinations during the screening period. Patients who meet the inclusion and exclusion criteria will enter the treatment period. All subjects will complete the relevant examinations specified in the protocol during treatment to observe safety, tolerability, and efficacy.
The subject has a full understanding of the study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).
Female, aged 18 to 75 years (inclusive).
Life expectancy ≥ 3 months, as assessed by the investigator.
Histologically confirmed squamous cell carcinoma of the cervix, vagina, or vulva.
Known hypersensitivity or allergic reaction to any study drug or its components.
Use of a strong CYP3A4 inducer (e.g., anticonvulsants [phenytoin, phenobarbital, carbamazepine], rifampicin, rifabutin, St. John's Wort) within 2 weeks prior to the first dose of study medication; or use of a strong CYP3A4 inhibitor (e.g., grapefruit juice, clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or a strong UGT1A1 inhibitor (e.g., atazanavir, gemfibrozil, indinavir) within 1 week prior to the first dose.
Known central nervous system (CNS) metastases, meningeal metastases, spinal cord metastases or spinal cord compression.
Currently having uncontrolled systemic diseases (e.g., progressive infection, uncontrolled hypertension, diabetes mellitus, etc.), or psychiatric disorders/social conditions that would limit the subject's ability to comply with study requirements or provide written informed consent.
Single group
Becotatug Vedotin in combination with Zimberelimab
DrugVebicoratamab 2.0 mg/kg, administered intravenously on Day 1 of each cycle Sintilimab 240 mg, administered intravenously on Day 1 of each cycle Each treatment cycle is 3 weeks.
The objective response rate of the treatment
The objective response rate of the treatment
duration of response
progression free survival
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Overall Survival
OS is defined as the time from randomization to death due to any cause.
Adverse Events
Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
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