Efficacy and Safety of QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma: a Phase II Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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):

∙ 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 subjects with liver metastasis, AST and ALT ≤5 × ULN. Total bilirubin (TBIL) ≤1.5 × ULN (subjects with Gilbert syndrome: TBIL \<3 × ULN). Albumin (ALB) ≥30 g/L.

‣ 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; subjects with \<1 g/day are eligible.

‣ Cardiac function: Left ventricular ejection fraction (LVEF) ≥50%.

⁃ 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.

Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Jin Wang
dengchzh@sysucc.org.cn
86+020-87340519
Time Frame
Start Date: 2025-09-28
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 45
Treatments
Experimental: Experimental:QL1706
Drug QL1706
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov