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This is a first-in-human (FIH), dose-escalation, PK expansion, monotherapy efficacy expansion, and open-label phase I clinical study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QL1604 injection (a humanized anti-PD-1 monoclonal antibody)in patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1604 injection | Experimental | Participants will receive QL1604 injection 0.3 mg/kg,1mg/kg, 3mg/kg,10mg/kg, or 200mg intravenous every 2 weeks or every 3 weeks and will be continued until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1604 injection | Drug | Participants will receive QL1604 injection 0.3 mg/kg,1mg/kg, 3mg/kg,10mg/kg, or 200mg intravenous every 2 weeks or every 3 weeks and will be continued until disease progression or unacceptable toxicity. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Dose-limiting toxicity (DLT) | Up to 21 days after the first dose |
| maximum tolerated dose(MTD) | maximum tolerated dose(MTD) | Up to 21 days after the first dose |
| recommended phase II dose (RP2D) | recommended phase II dose (RP2D) | up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs | according to NCI CTCAE V5.0 | up to 2 years |
| Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of The University of Chinese Academy of Sciences | Hangzhou | Zhejiang | 310022 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37936687 | Derived | Huang Z, Xu Y, Hong W, Gong L, Chen K, Qin J, Xie F, Wang F, Tian X, Meng X, Feng W, Li L, Zhang B, Kang X, Fan Y. A first-in-human, open-label, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of QL1604, a humanized anti-PD-1 mAb, in patients with advanced or metastatic solid tumors. Front Immunol. 2023 Oct 23;14:1258573. doi: 10.3389/fimmu.2023.1258573. eCollection 2023. |
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Maximum Concentration (Cmax)
| up to 2 years |
| Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants | Time to Maximum Concentration (Tmax) | up to 2 years |
| Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants | Terminal Half-Life (t ½) | up to 2 years |
| Area Under the Concentration-Time Curve of QL1604 From Time 0 to Day 28 (AUC 0-22) in Solid Tumor Participants | Area Under the Concentration-Time Curve | up to 22 days |
| Objective Response Rate (ORR) According to RECIST 1.1 | Objective Response Rate (ORR) According to RECIST 1.1 | up to 2 years |
| Disease Control Rate (DCR) According to RECIST 1.1 | Disease Control Rate (DCR) According to RECIST 1.1 | up to 2 years |