Actively Recruiting
SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer
Led by Fujian Cancer Hospital · Updated on 2026-03-30
89
Participants Needed
14
Research Sites
150 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a prospective, single arm II clinical trial. The main objective of the study is to evaluate the efficacy and safety of the combination of Sacituzumab Tirumotecan (SKB264) and QL1706 in the treatment of recurrent or metastatic cervical cancer.
CONDITIONS
Official Title
SKB264 Plus QL1706 in Recurrent or Metastatic Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, aged 18 years or older at the time of consent
- Diagnosed with recurrent or metastatic cervical cancer (including squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma) not suitable for surgery or radiotherapy
- Experienced failure or intolerance of at least one prior platinum-based chemotherapy regimen in the recurrent or metastatic setting, or progression during or within 6 months after platinum-based neoadjuvant or adjuvant chemotherapy
- At least one measurable lesion according to RECIST v1.1 criteria
- ECOG performance status of 0 or 1 within 7 days before dosing
- Expected survival of at least 12 weeks
- Recovered from prior therapy toxicities except those not considered safety risks
- Adequate organ and bone marrow function without recent transfusions or growth factor therapy
- Female participants of childbearing potential must agree to effective contraception from consent until 6 months after last dose
- Voluntary informed consent and ability to comply with study visits and procedures
You will not qualify if you...
- History of other active malignancies requiring treatment within the past 5 years (except certain skin cancers)
- Known active central nervous system metastases, including leptomeningeal, brainstem, or spinal cord involvement; stable brain metastases allowed under strict conditions
- Significant cardiovascular disease within 6 months prior to study, including severe heart failure, unstable angina, severe arrhythmias, myocarditis, cardiomyopathy, or prolonged QTc
- Severe or uncontrolled concurrent diseases such as decompensated liver cirrhosis, nephrotic syndrome, uncontrolled or severe hypertension, symptomatic pleural or pericardial effusion, or ascites needing repeated drainage
- Active hepatitis B or C infection
- Poorly controlled HIV infection
- Active tuberculosis
- History of severe dry eye syndrome or corneal diseases affecting healing
- History of fistula of the female reproductive tract unless fully recovered
- Major surgery within 30 days prior to first dose or not recovered from surgery
- Allergies or severe hypersensitivity to study drugs or monoclonal antibodies
- History or presence of interstitial lung disease or pneumonitis requiring steroids
- History of allogeneic tissue or organ transplantation
- Autoimmune disease requiring systemic treatment within past 2 years or needing immunosuppressives during study
- Prior treatment with TROP2-targeted therapy or topoisomerase I inhibitors
- Prior use of experimental anticancer vaccines or drugs targeting T-cell co-stimulation
- Live vaccine administration within 30 days before first dose or planned during study
- Use of strong CYP3A4 inhibitors or inducers within 2 weeks before first dose or during study
- Recent chemotherapy, radiotherapy, immunotherapy, biologics, TKIs, hormone therapy, or immunostimulants within defined timeframes before first dose
- Recent palliative radiotherapy to metastatic sites within 2 weeks before first dose
- Recent systemic anti-infection therapy within 1 week before first dose
- Systemic corticosteroid or immunosuppressive therapy above specified doses within 14 days before first dose
- Pregnancy or breastfeeding
- Any condition interfering with study drug evaluation, safety, or study results interpretation as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China, 350011
Actively Recruiting
2
Fujian Medical University Affiliated Second Hospital
Fuzhou, Fujian, China, 362000
Not Yet Recruiting
3
Zhangzhou Affiliated Hospital of Fujian Medical University
Zhangzhou, Fujian, China, 363000
Actively Recruiting
4
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Not Yet Recruiting
5
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530213
Not Yet Recruiting
6
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China, 010030
Not Yet Recruiting
7
The Second Hospital of Dalian Medical University
Dalian, Liaoning, China, 116027
Not Yet Recruiting
8
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
9
The Second Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Not Yet Recruiting
10
Shandong Provincial Hospital
Jinan, Shandong, China, 250013
Not Yet Recruiting
11
Cancer Hospital of Shandong First Medical University
Jinan, Shandong, China, 250117
Not Yet Recruiting
12
Affiliated Hospital of Jining Medical University
Jining, Shandong, China, 272113
Not Yet Recruiting
13
Qilu Hospital of Shandong University(Qingdao)
Qingdao, Shandong, China, 266011
Not Yet Recruiting
14
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030013
Not Yet Recruiting
Research Team
Q
Qin Xu, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here