Actively Recruiting
An Open Label, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, and Efficacy of SHR-A2102 Combined With Other Anti-cancer Agents in Advanced Urothelial Carcinoma
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-11-18
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of SHR-A2102 combined with other anti-cancer agents in patients with advanced urothelial carcinoma. This study aims to find a suitable dose of SHR-A2102 for this advanced cancer type and includes participants who have either failed or are intolerant to standard treatments or have not received systemic antitumor therapy for their condition. Participants will receive SHR-A2102 together with Adebrelimab injection and SHR-8068 injection as experimental treatments. The study is conducted in phases, including Phase Ib to determine the recommended dose and Phase II to assess the treatment's anti-tumor response. Treatment effects and safety will be monitored for up to approximately five years. During the study, participants will undergo tumor tissue sampling, disease measurement using RECIST criteria, and regular assessments for adverse events and treatment responses. Researchers will track outcomes like overall response rate, disease control rate, duration of response, progression-free survival, and overall survival. Safety monitoring includes evaluating immune-related side effects and pharmacokinetic measures of the drugs. Participation may last several years to gather long-term data on treatment effects and tolerability.
CONDITIONS
Brief Title
A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and sign an informed consent form.
- Male or female aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Histologically confirmed locally advanced or metastatic urothelial cancer.
- For Phase Ib: patients must have failed, be intolerant to, or refuse standard treatment.
- For Phase II: patients must not have received systemic antitumor therapy for advanced disease.
- Provide an archival or fresh tumor tissue sample.
- Have measurable disease according to RECIST version 1.1.
You will not qualify if you...
- Untreated, uncontrolled, or active central nervous system metastases.
- Previous treatment with TOPO1-based antibody-drug conjugates.
- Anti-cancer treatment within 4 weeks before first study dose.
- Radiotherapy within 14 days, or chest radiotherapy over 30Gy within 6 months before first study dose.
- Ongoing significant toxicity from prior treatments above Grade 1.
- Systemic immunosuppressant treatment within 14 days before first study dose.
- Known or suspected interstitial pneumonitis.
- For Phase Ib: history of Grade 3 or higher immune-related adverse events from prior immune checkpoint inhibitors.
- Active, known, or suspected autoimmune diseases.
- Moderate or severe symptomatic ascites, uncontrolled pleural effusion, or pericardial effusion.
- Uncontrolled cardiac diseases or cardiac symptoms.
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 - Up to approximately 5 years
Participants receive the study drugs SHR-A2102, Adebrelimab injection, and SHR-8068 injection as part of their antitumor therapy for advanced urothelial carcinoma.
Visits scheduled according to treatment and assessment needs during the study period
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
C
Chun Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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