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This a multi-center, open-label, non-randomized phaseâ… b trail. The purpose of this study was to evaluate the efficacy and safety of QL1706 in patients with advanced solid tumors and to investigate the immunogenicity and pharmacokinetic characteristics of QL1706.
The study was divided into screening/baseline, treatment and follow-up periods. Efficacy assessment and safety monitoring will be conducted throughout the study period.
Subjects will continue study treatment until disease progression occurs (unless the investigator believes there is a sustained clinical benefit) or other criteria for discontinuing study treatment are met, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 injection | Experimental | This clinical trail is a single arm study, all the patients that meet the entry criteria will receive treatment until disease progression occurs or meet other criteria for the discontinuation of treatment. QL1706 will be administered by intravenous infusion, 5 mg/kg, Q3W. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 injection | Drug | 5 mg/kg, IV, Q3w |
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| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | ORR includes complete response (CR) and partial response (PR) cases. According to RECIST V1.1, the first appearance of PR or CR requires additional imaging to confirm the lesion at ≥4 weeks. | up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| disease control rate (DCR) | DCR refers to the percentage of the cases in which the best efficacy rating is complete response (CR) or partial response (PR) or stable disease (SD). | up to 24 weeks |
| progression-free survival (PFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, Doctor | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41045933 | Derived | Ma Y, Lin S, Chen Q, Xue J, Yang Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Li W, Li Q, Zhu C, Huang Z, Kang X, Xue S, Li H, Wang C, Luo F, Huang Y, Zhang L, Zhao H. Updated efficacy and predictive biomarkers of QL1706, a bifunctional PD-1/CTLA-4 dual blocker in advanced solid tumors-A phase 1/1b study. Cell Rep Med. 2025 Oct 21;6(10):102396. doi: 10.1016/j.xcrm.2025.102396. Epub 2025 Oct 3. | |
| 37158938 |
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Progression-free survival (PFS) is defined as the time between a subject's first infusion QL1706 injection and their first radiographic evaluation of disease progression or death from any cause, whichever comes first.
| From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
| overall survival time (OS) | Overall survival (OS) is the time between the subject's first infusion QL1706 injection and death from any cause. | From date of enrollment until the date of death from any cause, assessed up to 24 months |
| adverse event (AE) | The rates and severity of AEs after QL1706 injection | up to 90 days after the last QL1706 injection is administered. |
| Derived |
| Zhao Y, Ma Y, Zang A, Cheng Y, Zhang Y, Wang X, Chen Z, Qu S, He J, Chen C, Jin C, Zhu D, Li Q, Liu X, Su W, Ba Y, Hao Y, Chen J, Zhang G, Qu S, Li Y, Feng W, Yang M, Liu B, Ouyang W, Liang J, Yu Z, Kang X, Xue S, Yang G, Yan W, Yang Y, Liu Z, Peng Y, Fanslow B, Huang X, Zhang L, Zhao H. First-in-human phase I/Ib study of QL1706 (PSB205), a bifunctional PD1/CTLA4 dual blocker, in patients with advanced solid tumors. J Hematol Oncol. 2023 May 8;16(1):50. doi: 10.1186/s13045-023-01445-1. |