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Bone and Soft Tissue TumorsPhase 2NCT06939855

QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma

A Phase 2 study testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4) in people with Bone and Soft Tissue Tumors, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Bone and Soft Tissue Tumors
What is being tested?
QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
28 Sep 2025to 1 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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 treatment.
  • 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 the prostate, cervix, or breast are not restricted by time.
  • 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). Subjects treated more than 5 years earlier and with no clinical evidence of disease recurrence within the past 5 years may be eligible.
  • Presence of brain metastasis. Subjects 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, systemic lupus erythematosus, interstitial lung disease, uveitis, ulcerative colitis, autoimmune hepatitis, hypophysitis, systemic vasculitis, nephritis, hyperthyroidism, hypothyroidism, mixed connective tissue disease. Subjects with vitiligo or fully resolved childhood asthma without intervention in adulthood are eligible. Asthma requiring bronchodilator therapy is not eligible. Physiologic replacement therapy (thyroxine, insulin, or corticosteroids for adrenal or pituitary insufficiency) is not considered systemic therapy.
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  • 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:
  • 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.
  • Atrial fibrillation or clinically significant supraventricular/ventricular arrhythmias requiring treatment.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jin Wang contact

86+020-87340519

dengchzh@sysucc.org.cn

China1 site, 1 recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Chuangzhong Deng, dengchzh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

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

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.

Being tested
QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
Keywords
QL1706
Medical subject headings
Soft Tissue Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QL1706 (bispecific antibody targeting PD-1 and CLTA-4)Drug

    5mg/kg iv q3w

Study groups in NCT06939855
Study groupRoleWhat they receive
Experimental：QL1706ExperimentalDrug QL1706
Receives: Drug: QL1706 (bispecific antibody targeting PD-1 and CLTA-4)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 12 week PFS

    The PFS rate at 12 weeks after the first injection assessed by the the investigator according to RECIST V1.1

    Measured: 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 (2)

  1. overall response rate (ORR)

    The ORR assessed by the investigator according to RECIST V1.1

    Measured: 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

  2. The Disease Control Rate (DOR)

    The DOR assessed by the investigator according to RECIST V1.1

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2025
  2. Study start28 Sep 2025
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06939855
Sponsor's protocol ID
B2025-200-X01
Status last verified
Nov 2025
First submitted
15 Apr 2025
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing QL1706 (bispecific antibody targeting PD-1 and CLTA-4) in people with Bone and Soft Tissue Tumors, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jin Wang (86+020-87340519, dengchzh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

12 week PFS (time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed at 12 weeks after first treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06939855.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.

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