Clinical trial NCT06939855: QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
Official title: Efficacy and Safety of QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma: a Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bone and Soft Tissue Tumors
Keywords: QL1706
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. Male or female subjects aged between 18 and 75 years .
2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
3. An unresectable locally advanced or metastatic sarcoma of bone and soft tissue confirmed by local histopathology, including acinar soft tissue sarcoma, pleomorphic undifferentiated sarcoma, chordoma, hemangiosarcoma and synovial sarcoma.
4. For subtypes without standard systemic treatment options, such as acinar soft tissue sarcoma, chordoma, no systemic treatment needed.
5. For subtypes with standard systemic treatment options, such as synovial sarcoma, pleomorphic undifferentiated sarcoma, and angiosarcoma, anthracycline-based chemotherapy is required.
6. Subjects can provide tumor tissue samples and blood samples for biomarker testing such as PD-L1.
7. Life expectancy of ≥3 months.
8. The functional level of important organs must meet the requirements before the first dose of study drug.
9. Male and female patients able to have children must agree to use highly effective method of contraception throughout the study and for at least 180 days after last dose.Female subjects who are not pregnant or breastfeeding.
10. Subjects participate voluntarily with sign a signed informed consent form (ICF) and are able to follow the study protocol.

Exclusion Criteria:

1. Active or prior documented autoimmune disease. Subjects who have stable hypothyroidism with hormone replacement ,childhood atopy or asthma, vitiligo, alopecia, , or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.
2. Grade 3 or Grade 4 irAEs related to prior cancer immunotherapy.
3. Known symptomatic brain metastases, leptomeningeal disease or spinal cord compression.
4. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment on decision of investigator. .
5. Any condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days before first dose of study drug. Corticosteroids for topical use, nasal spray, and inhaled steroids are allowed. Systemic corticosteroids for prophylaxis of contrast allergy are permitted.
6. Systemic anti-cancer treatment. This includes radiotherapy ,small molecule targeted therapy\<2 weeks before the first dose of study drug, ≤4 weeks for chemotherapy，monoclonal antibody;≤8 weeks for cell-based therapy or anti-tumor vaccine.
7. Major surgery within 28 days before the first dose of study drug and not recovered fully from any complications from surgery.
8. Systemic infection requiring IV antibiotic therapy or other serious infection within 14 days before the first dose of study drug.
9. Subjects with the history of organ transplant or allogeneic hematopoietic stem cells transpalnt.
10. Positive for Human immunodeficiency virus（HIV）or Hepatitis B ,active Hepatitis C.
11. Active interstitial lung disease (ILD) or pneumonitis or a history of ILD.

Primary outcomes:
measure: 12 week PFS
timeFrame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed at 12 weeks after first treatment
Secondary outcomes:
measure: overall response rate (ORR)
timeFrame: 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
measure: The Disease Control Rate (DOR)
timeFrame: 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
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: