Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:QL1706 | Experimental | Drug QL1706 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 (bispecific antibody targeting PD-1 and CLTA-4) | Drug | 5mg/kg iv q3w |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12 week PFS | The PFS rate at 12 weeks after the first injection assessed by the the investigator according to RECIST V1.1 | From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed at 12 weeks after first treatment |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate (ORR) | The ORR assessed by the investigator according to RECIST V1.1 | Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years |
| The Disease Control Rate (DOR) |
Not provided
Inclusion Criteria:
Subjects 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, pleomorphic undifferentiated sarcoma, chordoma, angiosarcoma, and dedifferentiated liposarcoma.
For histological subtypes without standard systemic therapy, such as chordoma, prior systemic therapy is not required. Subjects with alveolar soft part sarcoma may be systemic therapy-naïve or have received systemic therapy excluding PD-1/PD-L1 inhibitors.
For histological subtypes with standard systemic therapy, such as undifferentiated sarcoma, leiomyosarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, and pleomorphic undifferentiated sarcoma, subjects must have received anthracycline-based chemotherapy. Subjects with angiosarcoma must have received paclitaxel- or anthracycline-based chemotherapy, and have developed metastasis or disease progression (≥10% increase in the sum of the longest diameters within 3 months), or be intolerant to standard therapy.
At least one measurable lesion as assessed by the investigator according to RECIST v1.1.
Subjects 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 days before testing):
Female subjects must be non-lactating, and a pregnancy test must be negative before enrollment.
Subjects of childbearing potential agree to use effective contraception from signing the ICF through at least 180 days after the last dose of study drug.
Exclusion Criteria:
(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 aneurysm requiring surgical repair.
(4) Atrial fibrillation or clinically significant supraventricular/ventricular arrhythmias requiring treatment.
(5) Symptomatic superior vena cava syndrome. (6) QTc >450 ms (male) or QTc >470 ms (female). (7) Hypertension not adequately controlled with medication (systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg), or history of hypertensive crisis or hypertensive encephalopathy.
11. Hereditary or acquired bleeding tendency or coagulation disorders. 12. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage.
13. Active infection or unexplained fever >38.5°C during screening. Fever confirmed to be cancer-related may be eligible.
14. Use of broad-spectrum antibiotics by any route within 30 days before first dose.
15. Systemic corticosteroid therapy (≥10 mg/day prednisone or equivalent) or other immunosuppressants (such as cyclosporine, cyclophosphamide, azathioprine, methotrexate, thalidomide) within 14 days before first dose, or use of immunostimulatory agents (such as interferons or interleukin-2) within 4 weeks.
16. Major surgery without fully recovered wound healing, severe fractures, therapeutic clinical trial, or traditional Chinese medicine treatment within 4 weeks before first dose; or use of traditional Chinese medicine within 2 weeks.
17. Adverse events from prior antitumor therapy not recovered to ≤Grade 1 (alopecia and cancer-related fatigue excepted, neurotoxicity allowed ≤Grade 2).
18. HIV infection, other acquired or congenital immunodeficiencies, or history of organ or allogeneic bone marrow transplantation (corneal transplantation excepted).
19. Positive hepatitis B surface antigen (HBsAg) and/or positive hepatitis B core antibody (HBcAb) with HBV DNA >1×10⁴ copies/mL (approximately >2000 IU/mL); or positive hepatitis C antibody (HCV-Ab) with HCV-RNA >1×10³ copies/mL. Subjects with dual positivity for HBsAg and HCV-RNA are excluded.
20. Receipt of live or attenuated vaccines within 30 days prior to first dose. 21. Known psychiatric disorders, epilepsy, dementia, or alcohol/drug abuse that may affect compliance.
22. Any condition including medical history, concomitant disease, treatment, or abnormal laboratory results that may confound study results, interfere with participation, or deemed not in the best interest of the subject by the investigator or sponsor.
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Wang | Contact | 86+020-87340519 | dengchzh@sysucc.org.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012983 | Soft Tissue Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The DOR assessed by the investigator according to RECIST V1.1 |
| Every 6 weeks, from the date of enrollment until the date of the last time that tumor imaging and assessment of disease has been done, assessed up to 2 years |