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

Summary

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.

Key Facts

Interventions

Conditions

Eligibility

Inclusion Criteria:

A subject must meet all of the following criteria to be eligible for enrollment:

1. The subject has a full understanding of the study, voluntarily agrees to participate, and signs the Informed Consent Form (ICF).
2. Female, aged 18 to 75 years (inclusive).
3. Life expectancy ≥ 3 months, as assessed by the investigator.
4. Histologically confirmed squamous cell carcinoma of the cervix, vagina, or vulva.
5. 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.
6. ECOG performance status of 0 or 1.
7. Presence of at least one measurable target lesion according to the RECIST 1.1 criteria.
8. Adequate bone marrow function: absolute neutrophil count ≥ 1.5 × 10⁹/L, platelets ≥ 90 × 10⁹/L, hemoglobin ≥ 90 g/L.
9. Adequate hepatic and renal function: serum creatinine ≤ 1.5 × upper limit of normal (ULN); AST and ALT ≤ 2.5 × ULN (≤ 5 × ULN for subjects with liver metastases); total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for subjects with liver metastases).
10. 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 signing the ICF until 6 months after the last study drug administration.
11. Agrees to provide blood and histology samples.

Exclusion Criteria:

A subject will be ineligible for study enrollment if they meet any of the following criteria:

1. Known hypersensitivity or allergic reaction to any study drug or its components.
2. 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.
3. Known central nervous system (CNS) metastases, meningeal metastases, spinal cord metastases or spinal cord compression.
4. 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.
5. 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 chronic diarrhea), Crohn's disease, ulcerative colitis.
6. 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).
7. Human immunodeficiency virus (HIV) infection (positive HIV antibody test).
8. 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).
9. Pregnant or breastfeeding women; or women of childbearing potential who refuse to adopt effective contraceptive measures.
10. Any other condition deemed unsuitable for study participation by the investigator.

Outcome Measures

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