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New treatment option for Uterine Cervical Neoplasms, Recurrent; Uterine Cervical Neoplasms,...
Official title A Single-arm, Multicenter Clinical Study of Becotatug Vedotin Combined With Zimberelimab in the Treatment of Recurrent and Metastatic Cervical Cancer, Vulvar Cancer and Vaginal Cancer
ClinicalTrials.gov ID: NCT07424664
What this study is testing
What is Becotatug Vedotin in combination with Zimberelimab?
Becotatug Vedotin in combination with Zimberelimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for uterine cervical neoplasms, recurrent; uterine cervical neoplasms, metastatic; vulvar neoplasms; vaginal neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- A subject must meet all of the following criteria to be eligible for enrollment:
- 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.
You likely can't join if
- A subject will be ineligible for study enrollment if they meet any of the following criteria:
- 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...
- 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...
- Radiologically confirmed intestinal obstruction; or a medical history of the following diseases: inflammatory bowel disease, extensive bowel...
See the full eligibility criteria
- A subject must meet all of the following criteria to be eligible for enrollment:
- 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.
- Have received at least one line of standard therapy, which must have included platinum-based chemotherapy and an immunotherapy agent; prior lines of therapy ≤ 4.
- ECOG performance status of 0 or 1.
- Presence of at least one measurable target lesion according to the RECIST 1.1 criteria.
- Adequate bone marrow function: absolute neutrophil count ≥ 1.5 × 10⁹/L, platelets ≥ 90 × 10⁹/L, hemoglobin ≥ 90 g/L.
- Adequate hepatic and renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for people with liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for people with...
- Not pregnant or breastfeeding. Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to enrollment and agree to use an appropriate method of contraception from the time of...
- Agrees to provide blood and histology samples.
- A subject will be ineligible for study enrollment if they meet any of the following criteria:
- 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...
- 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...
- Radiologically confirmed intestinal obstruction; or a medical history of the following diseases: inflammatory bowel disease, extensive bowel resection (partial colectomy or extensive small bowel resection complicated by...
- Active hepatitis B or hepatitis C infection (hepatitis B surface antigen positive with hepatitis B virus DNA \> 1 × 10³ copies/mL; hepatitis C virus RNA \> 1 × 10³ copies/mL).
- Human immunodeficiency virus (HIV) infection (positive HIV antibody test).
- Major surgery or severe trauma within 30 days prior to the first dose, or planned major surgery within 30 days after the first dose (as determined by the investigator).
- Pregnant or breastfeeding women; or women of childbearing potential who refuse to adopt effective contraceptive measures.
- Any other condition deemed unsuitable for study participation by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.