Actively Recruiting
A Study of SHR-A2102 Injection, Alone or with Antitumor Therapy, in Advanced Solid Tumors to Evaluate Safety and Effectiveness
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2024-12-31
80
Participants Needed
1
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of the drug SHR-A2102, alone or combined with antitumor therapy, in adults with advanced solid tumors. This study aims to find the appropriate dosage of SHR-A2102 for treating these tumors. The trial includes participants with advanced cancer who have either failed standard treatments or have not received systemic antitumor therapy. Participants will receive SHR-A2102 either by itself or together with Adebrelimab injection as part of their treatment. The study is open-label and involves multiple centers. The treatment period covers dose escalation and evaluation phases, focusing on the safety and best dose of SHR-A2102. During the study, participants will be closely monitored for side effects from the first dose through 90 days after their last dose. Researchers will also measure tumor response up to 18 months after the last patient joins the study. Assessments include medical exams, laboratory tests, and imaging to track treatment effects and safety over about one year of follow-up.
CONDITIONS
Official Title
A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent and follow the treatment and visit plans
- Age 18 years or older
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Diagnosed with locally advanced unresectable or metastatic solid tumors; stage Ib patients have failed standard treatment; stage II patients have not had systemic antitumor therapy
- Can provide archived or fresh tumor tissue
- At least one measurable tumor lesion by RECIST v1.1 criteria
- Good organ function
- Use of effective contraception for men with partners of childbearing age and for fertile women
You will not qualify if you...
- Untreated or uncontrolled active central nervous system metastases
- Previous treatment with antibody-drug conjugates containing topoisomerase I inhibitors; stage II patients previously treated with PD-1/PD-L1 inhibitors
- Systemic antitumor therapy within 4 weeks before starting the study
- Palliative radiotherapy within 14 days before first dose; chest radiotherapy over 30 Gy within 6 months before starting
- Toxicities from prior antitumor therapy not resolved to mild levels (NCI-CTCAE 41)
- Systemic immunosuppressive therapy within 14 days before first dose
- Known or suspected interstitial pneumonia
- Grade 3 or higher immune-related adverse events from previous immune checkpoint inhibitors
- Any active, known, or suspected autoimmune disease
- Moderate or severe ascites with symptoms, uncontrolled moderate or higher pleural or pericardial effusion
- Uncontrolled cardiac symptoms or diseases
- Any other cancer diagnosed within the past 5 years
- Severe infection within 28 days before first dose
- Active hepatitis B or C
- Active tuberculosis within 1 year or untreated past active tuberculosis
- Immune deficiency history
- Live attenuated vaccines within 28 days before or during study
- Participation in another clinical study within 4 weeks or five half-lives of prior investigational drug
- Major surgery within 28 days or minor traumatic surgery within 7 days before first dose; non-healing wounds or untreated fractures
- Known severe allergic reactions to SHR-A2102 or related drugs
- Pregnant or planning pregnancy during the study
- Uncontrolled mental illness, substance abuse, or conditions interfering with study completion
- Other circumstances judged by investigators to increase risk or interfere with study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
C
Chi Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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