Actively Recruiting
A Phase II Single-arm Study of RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer
Led by Peking Union Medical College Hospital · Updated on 2023-10-02
30
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining RC48 with Tislelizumab as a second-line treatment for patients with HER2-expressing recurrent cervical cancer. This single-center, single-arm Phase II study focuses on women who have previously undergone first-line standard treatment and now have recurrent disease. The study includes a safety introduction period to monitor initial patients closely for any dose-limiting toxicities related to RC48. Participants receive RC48 as an intravenous drip at a dose of 2 mg/kg every two weeks and Tislelizumab as a fixed 600 mg intravenous drip every six weeks. The first six subjects are observed for 28 days after the initial dose to assess safety. If significant toxicities are observed, the RC48 dose may be reduced to 1.5 mg/kg for later participants. After this safety period, no replacements for early withdrawals will be made. During the trial, participants undergo regular assessments to monitor their response to treatment, including measuring the objective response rate up to three years after randomization. Researchers also track overall survival, progression-free survival, disease control rate, and duration of response. Safety, laboratory tests, and clinical evaluations are conducted throughout the study, which lasts until August 2026.
CONDITIONS
Brief Title
RC48 Combined With Tislelizumab for Second-line Treatment of HER2 Expression in Recurrent Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects aged from 18 to 75 years old
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
- Life expectancy of at least 6 months as judged by the investigator
- Histologically or cytologically confirmed primary cervical cancer including squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma, or small cell (neuroendocrine) cervical cancer
- Measurable disease assessable by RECIST v1.1
- Pathological diagnosis of HER2 expression (IHC 3+, IHC 2+, or IHC 1+) in advanced cervical cancer
- Negative blood pregnancy test for women of childbearing potential
- Use of highly effective contraception if there is a risk of pregnancy
You will not qualify if you...
- History of malignant tumors other than cervical cancer, except if disease-free for 5 years after curative treatment or successful resection of certain carcinoma in situ
- Previous malignant disease within the last 5 years except for specific skin or carcinoma in situ types
- Prior anti-tumor systemic therapy within 4 weeks before this study or unresolved side effects above grade 1 (except alopecia and pigmentation)
- Receipt of live vaccine within 4 weeks before study dosing or planned vaccine (except COVID-19) during the study
- Known congenital or acquired immunodeficiency
- Previous treatment with other antibody-coupled drugs
- Unrecovered surgery or serious postoperative complications
- Known or suspected allergy to the study drug
- Heart failure classified as NYHA grade 3 or above
- Active or poorly controlled severe infections including HIV, hepatitis B or C, tuberculosis, or other uncontrolled infections
- Significant clinical or laboratory abnormalities affecting safety such as uncontrolled diabetes, chronic kidney disease, peripheral neuropathy grade 2 or above, thyroid dysfunction
- Other conditions deemed unsuitable by researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
The first 6 participants receive the study drugs and are closely monitored for safety for 28 days after the first dose to identify any dose limiting toxicities.
Visits during the 28-day safety monitoring period
Duration - Until disease progression or discontinuation
Participants receive RC48 by intravenous drip every 2 weeks and Tislelizumab by intravenous drip every 6 weeks as second-line treatment for HER2 expression in recurrent cervical cancer.
Infusions every 2 weeks for RC48 and every 6 weeks for Tislelizumab with associated visits
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
Lei Li, PhD
X
Xiao Shang, PhD
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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