Becotatug Vedotin plus Zimberelimab in recurrent/metastatic cervical, vulvar, and vaginal cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, single-arm Phase 2 trial evaluating the combination of Becotatug Vedotin and Zimberelimab in patients with recurrent or metastatic cervical, vulvar, or vaginal cancers. Thirty participants will be enrolled and followed through a screening period, treatment period, and safety and survival follow-up. The treatment continues for up to one year or until disease progression, unacceptable toxicity, withdrawal of consent, or death. The study aims to characterize safety, tolerability, and preliminary efficacy of the novel ADC and PD-1 inhibitor combo in a population with limited options and prior platinum- and immunotherapy-exposed therapy. Prior data on similar antibody-drug conjugates and PD-1 inhibitors suggest potential synergy by directly killing tumor cells while reactivating immune responses.

Why it matters

Who can join: the full rules

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.

Where it's running

• Union Hospital, Huazhong University of Science and Technology
  Wuhan, Hubei, China Recruiting

Study contacts

• Principal investigator: Guiling Li, Doctor — Union Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China
• Study coordinator: Yao Jiang, Doctor
• Email: asdfjkl19@hotmail.com
• Phone: 027-83262598

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.