Actively Recruiting
A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer
Led by RemeGen Co., Ltd. · Updated on 2024-02-28
116
Participants Needed
12
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the efficacy,safety of RC48-ADC in Combination with Zimberelimab Injection for the Treatment ,at least first-line platinum-containing standard therapy failed in HER2-expressing subject with Recurrent or Metastatic Cervical Cancer
CONDITIONS
Official Title
A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histologically confirmed HER2-expressing recurrent or metastatic cervical cancer
- Failed at least one line of standard platinum-containing therapy
- Not suitable for surgery or radiotherapy
- Voluntarily agreed and signed informed consent
- Expected survival of at least 12 weeks
- Central laboratory confirmation of HER2 expression (IHC 1+, 2+, or 3+); IHC 2+ requires FISH testing
- Central laboratory confirmation of PD-L1 expression
- Measurable disease according to RECIST 1.1
- ECOG performance status 0 or 1
- Adequate organ function including ANC ≥1,500/µL, platelet count ≥100,000/µL, hemoglobin ≥9.0 g/dL, bilirubin within specified limits, creatinine clearance ≥50 mL/min, ALT and AST within specified limits, and LVEF ≥50%
- Female subjects must be surgically sterilized, post-menopausal, or agree to use approved contraception during and for 6 months after treatment, have a negative pregnancy test within 7 days prior to study entry, and be non-lactating
- Willingness and ability to comply with study and follow-up procedures
You will not qualify if you...
- Presence of central nervous system metastases or carcinomatous meningitis
- Received anti-tumor therapy or participated in another clinical study within 4 weeks prior to study treatment
- Unresolved toxicity from previous antineoplastic therapy above grade 1
- Major surgery with incomplete recovery within 4 weeks prior to dosing
- Positive serum virology for HBV, HCV (unless RNA negative), or HIV
- Received live or live attenuated vaccine within 4 weeks prior to dosing or plan to receive during study
- Grade 3 or higher heart failure
- History of gastrointestinal perforation or fistula within 6 months
- Serious thrombotic events or cardiovascular accidents within 1 year prior to study drug
- Active or progressive infection requiring systemic therapy or severe infection within 4 weeks prior to dosing
- Active tuberculosis
- Systemic disease not under stable control
- History of various lung diseases or active pneumonia
- Clinically relevant pyelonephrosis not relieved by stents or drainage
- Active autoimmune disease requiring systemic therapy within 2 years prior to dosing
- Other malignancy within 5 years prior to dosing
- Previous allogeneic hematopoietic stem cell transplantation
- Previous treatment with other antibody-drug conjugates
- Known hypersensitivity to study drugs or monoclonal antibodies
- Any other disease or abnormality affecting study participation
- Estimated poor adherence to study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China, 233000
Not Yet Recruiting
2
Beijing Obstetrics and Gynecology Hospital ,Capital Medical University
Beijing, Beijing Municipality, China, 100026
Not Yet Recruiting
3
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Not Yet Recruiting
4
Guangxi Tumor Hospital
Nanning, Guangxi, China, 530021
Not Yet Recruiting
5
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Not Yet Recruiting
6
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China, 330008
Not Yet Recruiting
7
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110801
Not Yet Recruiting
8
Shandong Cancer Hospital & Institute
Jinan, Shandong, China, 250117
Not Yet Recruiting
9
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
10
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China, 300181
Not Yet Recruiting
11
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650118
Not Yet Recruiting
12
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Not Yet Recruiting
Research Team
J
Jianmin Fang, 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
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