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.
Recurrent and metastatic cervical, vulvar, and vaginal cancers represent a significant clinical challenge, with limited treatment options and poor prognosis for patients who have failed standard therapies. These malignancies are often driven by persistent human papillomavirus (HPV) infection, leading to immunosuppression and tumor immune evasion. While immune checkpoint inhibitors, such as anti-PD-1 antibodies, have shown some efficacy, response rates remain suboptimal, highlighting the need for more effective combination strategies. Becotatug vedotin is an antibody-drug conjugate (ADC) that selectively delivers a potent cytotoxic payload to tumor cells expressing specific antigens, thereby inducing targeted cell death. Zimberelimab is a monoclonal antibody targeting the PD-1 checkpoint receptor, which functions to reactivate the body's immune system to recognize and attack cancer cells. The combination of these two agents is hypothesized to exert a synergistic anti-tumor effect, by directly eliminating tumor cells while simultaneously overcoming immunosuppression in the tumor microenvironment. This trial will evaluate the safety, tolerability, and preliminary efficacy of this novel combination regimen.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Vebicoratamab 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
Time frame: Up to approximately 36 months
duration of response
Time frame: Up to approximately 36 months
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.
Time frame: Up to approximately 36 months
Overall Survival
OS is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.