A Phase 1 interventional study of QL1706 in HCC - Hepatocellular Carcinoma, sponsored by Wan-Guang Zhang. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Wan-Guang Zhang · Phase 1, Interventional, and Treatment
This is a phase I trial to assess the safety and preliminary efficacy of QL1706 in Treating Advanced Hepatocellular Carcinoma Patients refractory to prior immunotherapy.
Immune checkpoint inhibitors (ICIs) have produced encouraging results in patients with hepatocellular carcinoma (HCC). Nonetheless, single-agent ICIs are effective in only 15% to 20% of HCC patients. According to the phase 3 LEAP-002 trial, lenvatinib combined with pembrolizumab provides a limited survival advantage over lenvatinib. In China, local treatments combined with tyrosine kinase inhibitors (TKIs) and anti-PD-1 antibodies have been used as the first-line treatment of advanced HCC. However, due to the heterogeneity of cancer, patient responses to monotherapy or combination therapy vary considerably, and only some patients benefit from such therapy. Hence, there is an unmet need to investigate the appropriate treatment for the rapidly expanding group of patients with advanced HCC who had tumor progression on prior anti-PD-1 therapies. QL1706 (PSB205) is a single bifunctional MabPair (a novel technical platform) product consisting of two engineered monoclonal antibodies (anti-PD-1 IgG4 and anti-CTLA-4 IgG1), with a shorter elimination half-life (t1/2) for CTLA-4. The Single-arm, single-center study aims to evaluate the safety and efficacy of QL1706 in treating advanced HCC refractory to prior PD-1 immune checkpoint inhibitors.
3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.
This study's planned enrollment of 21 is below the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Wan-Guang Zhang is the lead sponsor of 4 studies on the registry; 4 are open to participants now.
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Drug: QL1706
Drug: QL1706
Drug: QL1706 7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
Median progression-free survival(mPFS)
measured from the date of first treatment to radiographically documented progression according to mRECIST 1.1 or death from any cause (whichever occurs first). Participants alive and without disease progression or lost to follow-up will be censored at the date of their last radiographic assessment.
Time frame: From randomization to the first occurrence of disease progression or death from any cause, whichever occurs earlier, assessed up to 1 year
overall response rate (ORR) measured by mRECIST criteria
Complete response (CR): Disappearance of any intra-tumoral arterial enhancement in all target lesions; Partial response (PR): At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions; Stable disease (SD): Any cases that do not qualify for either partial response or progressive disease; Progressive disease (PD): An increase of at least 20% in the sum of the diameters of viable (enhancing) target lesions, taking as reference the smallest sum of the diameters of viable (enhancing) target lesions recorded since treatment started. ORR=CR+PR.
Time frame: rom the date of first treatment to radiographically documented progression according to mRECIST, assessed up to 2 year
Overall survival (OS)
Overall survival (OS): measured from date of first treatment to the date of death from any cause. Participants alive or lost to follow-up will be censored at the date of their last visit.
Time frame: from the date of first treatment to the date of death from any cause, assessed up to 2 year
Disease control rate (DCR)
Percentage of patients that had a CR, PR, or SD ≥ 6 months per mRECIST
Time frame: from the date of first treatment to radiographically documented response according to mRECIST, assessed up to 2 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Adverse Events
Time frame: Up to 21 days post-the last treatment
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Aug 2026, 18 months later.
Of 126 non-industry phase 1 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 80. This study's planned 18 months is below that.
Counting every sponsor, half of 206 studies reached it within 49 months; a quarter within 31 and three quarters within 78.
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Iparomlimab/Tuvonralimab
Wan-Guang Zhang