Actively Recruiting
A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer
Led by Mabwell (Shanghai) Bioscience Co., Ltd. · Updated on 2024-11-22
420
Participants Needed
2
Research Sites
276 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate 9MW2821 Versus Treatment of Physician's Choice for Subjects With Recurrent or Metastatic Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged 18 to 75 years
- Ability to understand and sign informed consent
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Histologically confirmed recurrent or metastatic cervical cancer (squamous cell, HPV-associated adenocarcinoma, or adenosquamous)
- Cancer not suitable for surgery or chemoradiation with curative intent
- Received platinum-based chemotherapy with or without bevacizumab and no more than 2 prior systemic therapies in metastatic/recurrent setting
- Experienced radiographic disease progression during or after last treatment
- Provided archival or fresh tumor tissue sample
- Life expectancy of at least 12 weeks
- Measurable disease according to RECIST version 1.1
- Adequate organ function to receive chemotherapy regimens used in the study
- Willing to use contraception during and for at least 6 months after treatment if sexually active and fertile
- Willingness to comply with study procedures
You will not qualify if you...
- Cancer histologies not included in the study (e.g., HPV-independent adenocarcinoma, primary neuroendocrine)
- Chemotherapy or radiotherapy within 21 days before first study drug dose
- Use of traditional Chinese medicine with anticancer effects within 14 days before first study drug dose
- Use of investigational drugs or devices within 28 days before first study drug dose
- Prior treatment with nectin-4 targeted ADC or ADC with MMAE payload
- Use of strong CYP3A4 inhibitors within 14 days before first study drug dose
- Preexisting treatment-related toxicity Grade 2 or higher
- History of severe immune-related adverse events (Grade 3 or higher) from immunotherapy
- Unresolved or severe hydronephrosis
- Major surgery within 28 days before first study drug dose
- Hemoglobin A1C 8% or higher
- Preexisting peripheral neuropathy Grade 2 or higher
- Live vaccines within 28 days before or during the study
- Significant heart or cerebrovascular disease within 6 months before first study drug dose
- Severe or uncontrolled diseases such as respiratory disease, thromboembolic events, active bleeding or infection
- Central nervous system metastases
- Another cancer diagnosis within 3 years unless cured
- Autoimmune disease requiring systemic treatment within 2 years
- Eye conditions increasing risk of corneal damage
- Sensitivity to study drug ingredients, drug abuse, or mental illness
- Uncontrolled tumor-related bone pain or spinal cord compression
- Symptomatic pleural effusion, ascites, or pericardial effusion requiring drainage
- Any condition posing significant risk to the participant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
2
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
L
Lingying Wu, Professor
CONTACT
H
Huijuan Yang, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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