Actively Recruiting
QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
Led by Sun Yat-sen University · Updated on 2025-11-19
45
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, open-label phase II study of QL1706 for the treatment of advanced bone and soft tissue sarcomas.The study includes screening period, treatment period and follow-up period. Subjects will receive QL1706 5mg/kg iv every 3 weeks until disease progression or intolerance. Efficacy should be evaluated and safety will be monitored throughout the study.
CONDITIONS
Official Title
QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years at consent
- Histologically confirmed unresectable locally advanced or metastatic bone and soft tissue sarcoma, including specified subtypes
- For certain sarcoma subtypes, prior systemic therapy as required or allowed
- At least one measurable lesion per RECIST v1.1
- Ability to provide tumor tissue and blood samples for biomarker testing
- ECOG performance status 0-1 with expected survival of at least 12 weeks
- Clinical laboratory tests within specified limits, including hematologic, hepatic, renal, coagulation, urine protein, and cardiac function
- Female participants must be non-lactating and have a negative pregnancy test before enrollment
- Agreement to use effective contraception during and 180 days after study drug treatment
You will not qualify if you...
- History of severe allergic reactions to any monoclonal antibody or excipient
- Participation in other investigational drug/device studies with treatment within 4 weeks before study drug
- Other active malignancies within 5 years except certain cured localized cancers
- Prior treatment with immune checkpoint inhibitors or agents targeting T-cell receptor signaling within 5 years unless no disease recurrence
- Presence of brain metastases unless asymptomatic or stable after treatment for 4 weeks
- Active autoimmune disease requiring systemic therapy within 2 years
- Active pulmonary tuberculosis, pneumonitis, or significant pulmonary impairment
- Need for long-term or high-dose NSAIDs or anticoagulant therapy
- Significant gastrointestinal disorders
- Cardiovascular or cerebrovascular diseases including heart failure NYHA class II or higher, recent myocardial infarction or stroke, arrhythmias requiring treatment, uncontrolled hypertension, and others
- Bleeding or coagulation disorders
- Uncontrolled pleural, pericardial effusion, or ascites
- Active infection or unexplained fever above 38.5°C during screening
- Use of broad-spectrum antibiotics within 30 days before first dose
- Systemic corticosteroids or immunosuppressants within specified timeframes before first dose
- Major surgery or treatments without fully recovered wound healing within 4 weeks
- Unresolved adverse events from prior antitumor therapy above specified grades
- HIV infection, immunodeficiencies, or history of organ/bone marrow transplantation
- Positive hepatitis B or C with viral load above specified levels
- Receipt of live or attenuated vaccines within 30 days before first dose
- Psychiatric disorders, epilepsy, dementia, or substance abuse affecting compliance
- Any condition or history that may interfere with study participation or results as judged by investigator or sponsor
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
J
Jin Wang
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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