QL1706 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
ConditionBone and Soft Tissue Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-sen University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
Drug5mg/kg iv q3w
Treatment groups
45 Participants
are divided into 1 treatment groupGroup A: Experimental：QL1706Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
12 week PFS
The PFS rate at 12 weeks after the first injection assessed by the the investigator according to RECIST V1.1
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 treatmentSecondary outcomes
1
overall response rate (ORR)
The ORR assessed by the investigator according to RECIST V1.1
Time frame
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 years2
The Disease Control Rate (DOR)
The DOR assessed by the investigator according to RECIST V1.1
Time frame
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 yearsSponsors and contacts
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Source ClinicalTrials.gov