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New treatment option for Bone and Soft Tissue Tumors
Official title QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
ClinicalTrials.gov ID: NCT06939855
What this study is testing
What is QL1706 (bispecific antibody targeting PD-1 and CLTA-4)?
QL1706 (bispecific antibody targeting PD-1 and CLTA-4) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bone and soft tissue tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- people voluntarily participate in the study, sign the informed consent form (ICF), and are able to comply with study procedures.
- Age ≥18 years and ≤75 years at the time of signing ICF, regardless of gender.
- Histologically confirmed unresectable locally advanced or metastatic bone and soft tissue sarcoma at this institution, including: undifferentiated...
- For histological subtypes without standard systemic therapy, such as chordoma, prior systemic therapy is not required. people with alveolar soft part...
- For histological subtypes with standard systemic therapy, such as undifferentiated sarcoma, leiomyosarcoma, myxofibrosarcoma, dedifferentiated...
You likely can't join if
- Known history of severe allergic reactions to any monoclonal antibody or any excipient in its formulation.
- Currently participating in and receiving investigational treatment, or participation in an investigational drug/device study with investigational...
- History of other active malignancies within 5 years prior to first dose. Cured localized malignancies such as basal cell carcinoma, squamous cell...
- Prior treatment with immune checkpoint inhibitors (PD-1/PD-L1 agents) or other agents targeting T-cell receptor signaling (for example CTLA-4...
- Presence of brain metastasis. people with asymptomatic brain metastasis or symptomatic metastasis that is stable for ≥4 weeks after treatment may be...
- Active autoimmune disease requiring systemic therapy (disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to...
See the full eligibility criteria
Who can join
- people voluntarily participate in the study, sign the informed consent form (ICF), and are able to comply with study procedures.
- Age ≥18 years and ≤75 years at the time of signing ICF, regardless of gender.
- Histologically confirmed unresectable locally advanced or metastatic bone and soft tissue sarcoma at this institution, including: undifferentiated sarcoma, leiomyosarcoma, myxofibrosarcoma, alveolar soft part sarcoma...
- For histological subtypes without standard systemic therapy, such as chordoma, prior systemic therapy is not required. people with alveolar soft part sarcoma may be systemic therapy-naïve or have received systemic...
- For histological subtypes with standard systemic therapy, such as undifferentiated sarcoma, leiomyosarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, and pleomorphic undifferentiated sarcoma, people must have...
- At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
- people are able to provide tumor tissue samples and blood samples for biomarker testing including PD-L1.
- ECOG performance status of 0-1, with an expected survival ≥12 weeks.
- Clinical laboratory tests at screening must meet the following criteria (no use of blood components, hematopoietic growth factors, leukocyte- or platelet-stimulating agents, or anemia-correcting medications within 14...
- Hematologic: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Platelet count (PLT) ≥90 × 10⁹/L; Hemoglobin (Hb) ≥90 g/L.
- Hepatic function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN); for people with liver metastasis, AST and ALT ≤5 × ULN. Total bilirubin (TBIL) ≤1.5 × ULN (people...
- Renal function: Serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance (CCr) ≥50 mL/min (calculated by Cockcroft-Gault formula).
- Coagulation: Activated partial thromboplastin time (APTT) ≤1.5 × ULN; International normalized ratio (INR) ≤1.5; Prothrombin time (PT) ≤1.5 × ULN.
- Urine protein: Urine protein dipstick ≤1+. If ≥2+, a 24-hour urine protein test is required; people with \<1 g/day are eligible.
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%.
- Female people must be non-lactating, and a pregnancy test must be negative before enrollment.
- people of childbearing potential agree to use effective contraception from signing the ICF through at least 180 days after the last dose of study drug.
What rules you out
- Known history of severe allergic reactions to any monoclonal antibody or any excipient in its formulation.
- Currently participating in and receiving investigational treatment, or participation in an investigational drug/device study with investigational treatment administered within 4 weeks before the first dose of study...
- History of other active malignancies within 5 years prior to first dose. Cured localized malignancies such as basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of...
- Prior treatment with immune checkpoint inhibitors (PD-1/PD-L1 agents) or other agents targeting T-cell receptor signaling (for example CTLA-4, OX-40). people treated more than 5 years earlier and with no clinical...
- Presence of brain metastasis. people with asymptomatic brain metastasis or symptomatic metastasis that is stable for ≥4 weeks after treatment may be enrolled.
- Active autoimmune disease requiring systemic therapy (disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to enrollment. Conditions include but are not limited to myasthenia gravis...
- Active pulmonary tuberculosis, radiation pneumonitis, drug-induced pneumonitis, or other significant pulmonary impairment during screening.
- Requirement for long-term or high-dose nonsteroidal anti-inflammatory drugs (aspirin ≥325 mg) or anticoagulant therapy.
- Clinically significant gastrointestinal disorders including, but not limited to, history of gastrointestinal bleeding or perforation, or acute pancreatitis.
- Cardiovascular or cerebrovascular diseases including: (1) Heart failure ≥NYHA class II. (2) Severe or unstable angina. (3) Myocardial infarction or cerebrovascular accident within 6 months before first dose, or aortic...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.