A Multicenter, Open Phase 1b Study to Evaluate the Efficacy and Safety of QL1706 Injection in Patients With Advanced Malignant Solid Tumors
Sponsor study identifier
interventional
419
1 country
1
Study Start
January 11, 2021
Actual (reported)Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This a multi-center, open-label, non-randomized phaseⅠb 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 11, 2021
Actual (reported)November 30, 2021
Actual (reported)December 29, 2021
Actual (reported)December 31, 2021
Actual (reported)December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
disease control rate (DCR)
up to 24 weeks
progression-free survival (PFS)
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)
From date of enrollment until the date of death from any cause, assessed up to 24 months
adverse event (AE)
up to 90 days after the last QL1706 injection is administered.
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.
5 mg/kg, IV, Q3w
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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.
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.
Li Zhang, Doctor
Sun Yat-sen University
419 participants (actual enrollment reported by the registry).
First Submitted
November 30, 2021
First Posted
December 29, 2021
Study Start
January 11, 2021
Actual (reported)A Study of KL340399 in Patients With Advanced Solid Tumors
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2021
Actual (reported)Study Completion
December 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 7, 2023
Record last verified: 2023-04
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Source: ClinicalTrials.gov.
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