Actively Recruiting
RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression
Led by Peking University Cancer Hospital & Institute · Updated on 2024-05-20
54
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the efficacy, safety, and quality of life scores of patients with HER2-expressing platinum-sensitive recurrent epithelial ovarian cancer treated with the combination therapy regimen of RC48 plus platinum with or without bevacizumab.
CONDITIONS
Official Title
RC48 Treatment for Platinum Sensitive Recurrent Ovarian Cancer With HER2 Expression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged from 18 to 75 years old
- Pathology confirmed diagnosis of primary epithelial ovarian, fallopian tube, or peritoneal carcinoma
- Prior treatment lines between 1 and 4, including first-line maintenance therapy after response
- No previous targeted HER2 drug therapy (including monoclonal antibodies and ADC drugs)
- Eastern Cooperative Oncology Group Performance Status of 0 to 1
- Measurable disease by RECIST 1.1 criteria
- Estimated life expectancy over 3 months
- Confirmed HER2 expression (IHC 1+, 2+, or 3+) from tumor samples
- Adequate blood, liver, and kidney function
- Negative pregnancy test for women of childbearing potential and use of effective contraception if at risk of pregnancy
You will not qualify if you...
- Non-epithelial ovarian, fallopian tube, or peritoneal cancer or metastatic ovarian cancer
- Grade 2 or higher peripheral neuropathy
- Active bleeding or conditions with high bleeding risk
- Central nervous system metastasis or cancerous meningitis (except stable brain metastases)
- Unresolved toxicity from prior cancer treatments above CTCAE level 1 (except hair loss)
- Need for parenteral hydration or nutrition with partial intestinal obstruction or perforation
- Certain stages or types of primary endometrial cancer not meeting specific criteria
- Major surgery within 4 weeks prior to study start without full recovery
- Large symptomatic pleural or ascitic fluid requiring treatment
- Recent live attenuated vaccines within 30 days or planned during study
- Serious thrombotic or cardiovascular events within one year prior
- Uncontrolled systemic diseases such as diabetes or liver cirrhosis
- Clinically significant cardiovascular disease
- Active autoimmune disease or immunodeficiency, except controlled hypothyroidism or insulin-controlled type 1 diabetes
- History of other malignant tumors within five years, except certain skin and cervical cancers
- Congenital or acquired immune deficiency including HIV or active hepatitis B or C
- Severe infection requiring intravenous treatment or unexplained fever before first dose
- Participation in other clinical trials or investigational treatments within 4 weeks prior
- Known allergies or intolerance to study drugs or similar agents
- History of substance abuse or psychiatric disorders preventing participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hong Zheng
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
H
Hong Zheng, M.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