A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer

NCT06692166 | Recruiting Phase 3 DMC

• 1 other identifier: 9MW2821-CP304
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the efficacy and safety of 9MW2821 and chemotherapy in participants with recurrent or metastatic cervical cancer who progressed on or after platinum-based chemotherapy.

Conditions

Cervical Cancer

Keywords

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time from the date of randomization until the date of death from any cause.

  Up to 3 years

Secondary Outcomes (7)

• Objective Response Rate per investigator

  Up to 3 years

• Disease Control Rate per investigator

  Up to 3 years

• Progression Free Survival per investigator

  Up to 3 years

• Duration of Response per investigator

  Up to 3 years

• Time to response per investigator

  Up to 3 years

Other Outcomes (2)

• Mean change from baseline in the European Organisation for Research and Treatment of Cancer (EORTC) 30-item core quality-of-life questionnaire (QLQ-C30）

  Up to 3 years

• EORTC Quality of Life Questionnaire Cervical Cancer Module (QLQ-CX24) Total Scores

  Up to 3 years

Study Arms (2)

9MW2821

EXPERIMENTAL

Drug: 9MW2821

Treatment of Physician's Choice

ACTIVE COMPARATOR

Drug: Chemotherapy

Interventions

9MW2821 DRUG

1.25mg/kg of 9MW2821 by intravenous infusion on days 1, 8 and 15 of every 28-day cycle

9MW2821

Chemotherapy DRUG

1.0 or 1.25 mg/m \^2 topotecan by intravenous infusion on days 1 to 5 or 1000 mg/m \^2 gemcitabine by intravenous infusion on days 1 and 8 or 500 mg/m \^2 pemetrexed by intravenous infusion on day 1 of every 21 days

Treatment of Physician's Choice

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (IEC/IRB/REB) approved informed consent form.
• Female subjects aged 18 to 75 years (including 18 and 75 years).
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous), not amenable to resection or chemoradiation with curative intent.
• Subject must have received a platinum-based chemotherapy with or without bevacizumab and received no more than 2 prior systemic therapy in the metastatic/recurrent setting. Subject must have experienced radiographic progression during or after the last treatment regimen.
• An archival tumor tissue sample or a fresh tissue sample should be provided.
• Life expectancy of ≥ 12 weeks.
• Subjects must have measurable disease according to RECIST (version 1.1).
• Adequate to receive one of the chemotherapy regimens in the control group (gemcitabine, pemetrexed, topotecan);
• Adequate organ functions.
• Sexually active fertile subjects must agree to use methods of contraception during the study and at least 6 months after termination of study therapy.
• Subjects are willing to follow study procedures.

You may not qualify if:

• Chemotherapy or radiotherapy within 21 days prior to the first dose of study drug, traditional Chinese medicine with anticancer indication within 14 days prior to the first dose of study drug, use of any investigational drug or device within 28 days prior to the first dose of study drug, received treatment of nectin-4 targeted ADC, received treatment of ADC with MMAE payload, received any strong CYP3A4 inhibitors within 14 days prior to the first dose of study drug.
• Preexisting treatment related toxicity Grade ≥ 2. Subjects experienced Grade ≥ 3 immune related adverse events during or after immunotherapy.
• Subjects had clinically significant hydronephrosis that could not be relieved by nephrostomy or urethral stenting, as determined by the investigator.
• Major surgery within 28 days prior to first dose of study drug.
• Hemoglobin A1C (HbA1c) ≥ 8%.
• Preexisting peripheral neuropathy Grade ≥ 2.
• Any live vaccines within 28 days before first dose of study drug or during the study.
• Documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug.
• Other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection.
• Central nervous system metastases.
• History of another malignancy within 3 years before the first dose of study drug. Subjects with cured malignancies are allowed.
• History of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug.
• Has ocular conditions that may increase the risk of corneal epithelium damage.
• Known sensitivity to any of the ingredients of the investigational product; History of drug abuse or mental illness.
• Uncontrolled tumor-related bone pain or spinal cord compression.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

Related Publications (1)

• Zhang J, Liu R, Wang S, Feng Z, Yang H, Gao S, Li X, Yao X, Chen J, Gong Z, Li Y, Li X, Wang S, Hu C, Liu J, Zhang M, Yuan F, Shi B, Lou H, Zhao P, Qiu F, Guo H, Hu B, Xu D, Huang H, Zhang X, Feng M, Wang X, Li G, Liu D, Chen X, Wang P. Bulumtatug Fuvedotin (BFv, 9MW2821), a next-generation Nectin-4 targeting antibody-drug conjugate, in patients with advanced solid tumors: a first-in-human, open-label, multicenter, phase I/II study. Ann Oncol. 2025 Aug;36(8):934-943. doi: 10.1016/j.annonc.2025.04.009. Epub 2025 Apr 25.

  PMID: 40288679 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Lingying Wu, Professor

CONTACT

+8601067781331; wulingying@csco.org.cn

Huijuan Yang, Professor

CONTACT

+8602164175590; huijuanyang@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 18, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): December 9, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: November 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)