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

February 13, 2026 updated by: Guiling Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Becotatug Vedotin in combination with Zimberelimab

Subjects who are enrolled in the study and pass the investigator's screening will receive treatment according to the following regimen:

Becotatug Vedotin 2.0 mg/kg, administered intravenously on Day 1 of each cycle Zimberelimab 240 mg, administered intravenously on Day 1 of each cycle Each treatment cycle is 3 weeks. Treatment will continue until the first occurrence of any of the following events: disease progression, unacceptable toxicity, completion of 12 months of treatment, initiation of new anti-cancer therapy, withdrawal of informed consent, loss to follow-up, death, or other circumstances that the investigator deems necessitate treatment discontinuation.
Drug: Becotatug Vedotin in combination with Zimberelimab
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The objective response rate of the treatment
Time Frame: Up to approximately 36 months
The objective response rate of the treatment
Up to approximately 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of response
Time Frame: Up to approximately 36 months
Up to approximately 36 months
progression free survival
Time Frame: Up to approximately 36 months
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Up to approximately 36 months
Overall Survival
Time Frame: Up to approximately 36 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: Up to approximately 36 months
Any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
Up to approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Investigators

  • Principal Investigator: Guiling Li, Doctor, Union Hospital, Huazhong University of Science and Technology, Wuhan, Hubei, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

March 15, 2027

Study Completion (Estimated)

March 15, 2028

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WB-PT-Cerv-Union01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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