OncoMatch/Clinical Trials/NCT06939855
QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
Is NCT06939855 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies QL1706 (bispecific antibody targeting PD-1 and CLTA-4) for bone and soft tissue tumors.
Treatment: QL1706 (bispecific antibody targeting PD-1 and CLTA-4) — 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.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Required: PD-L1 (CD274) any tested (testing required; no eligibility threshold specified)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline — for undifferentiated sarcoma, leiomyosarcoma, myxofibrosarcoma, dedifferentiated liposarcoma, pleomorphic undifferentiated sarcoma
subjects must have received anthracycline-based chemotherapy
Must have received: paclitaxel (paclitaxel) — for angiosarcoma
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.
Must have received: anthracycline — for angiosarcoma
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.
Cannot have received: anti-PD-1 therapy
Exception: Subjects treated more than 5 years earlier and with no clinical evidence of disease recurrence within the past 5 years may be eligible.
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).
Cannot have received: anti-PD-L1 therapy
Exception: Subjects treated more than 5 years earlier and with no clinical evidence of disease recurrence within the past 5 years may be eligible.
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).
Cannot have received: anti-CTLA-4 therapy
Exception: Subjects treated more than 5 years earlier and with no clinical evidence of disease recurrence within the past 5 years may be eligible.
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).
Cannot have received: OX-40 inhibitor
Exception: Subjects treated more than 5 years earlier and with no clinical evidence of disease recurrence within the past 5 years may be eligible.
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).
Lab requirements
Blood counts
ANC ≥1.5 × 10⁹/L; Platelet count ≥90 × 10⁹/L; Hemoglobin ≥90 g/L.
Kidney function
Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault).
Liver function
AST and ALT ≤2.5 × ULN; for subjects with liver metastasis, AST and ALT ≤5 × ULN. Total bilirubin ≤1.5 × ULN (subjects with Gilbert syndrome: TBIL <3 × ULN). Albumin ≥30 g/L.
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50%.
Clinical laboratory tests at screening must meet the following criteria: Hematologic: ANC ≥1.5 × 10⁹/L; Platelet count ≥90 × 10⁹/L; Hemoglobin ≥90 g/L. Hepatic: AST and ALT ≤2.5 × ULN; for subjects with liver metastasis, AST and ALT ≤5 × ULN. Total bilirubin ≤1.5 × ULN (subjects with Gilbert syndrome: TBIL <3 × ULN). Albumin ≥30 g/L. Renal: Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min (Cockcroft-Gault). Cardiac: LVEF ≥50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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