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This is a study for participants with advanced gastric or gastroesophageal junction adenocarcinoma who had tumor progression after first-line treatment with platinum and fluoropyrimidine doublet therapy. The study will be conducted in 2 parts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Cohort A | Experimental | Participants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years. |
|
| Experimental: Cohort B-arm1 | Experimental | Participants receive QL1604 and nab-paclitaxel on Days 1, 8, and 15 of each 28-day cycle. If not disease progression after 4 cycles, participants receive QL1604 monotherapy until disease progression、unacceptable toxicity or up to 2 years. |
|
| Experimental: Cohort B-arm2 | Experimental | Participants receive paclitaxel on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1604 | Drug | 3mg/kg, D1,8,15,Q4w, IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events (AE) and serious adverse events (SAE) according to CTCAE V5.0 | Safety and tolerability (stage 1) | Up to 90 days from last dose |
| The percentages of participants discontinuing or suspending the study drug due to an AE. | Safety and tolerability (stage 1) | Up to 90 days from last dose |
| Overall survival(OS)(stage 2) | Overall survival is defined as time from randomization to death due to any cause. | from the date of first dose until the date of death from any cause,assessed up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate(ORR)assessed by the investigators according to RECIST 1.1(stage 1 and 2) | Objective response rate(ORR)assessed by the investigators according to RECIST 1.1. | up to 2 years |
| Disease control rate(DCR)assessed by the investigators according to RECIST 1.1(stage 1 and 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shunjiang Yu, CMO | Contact | 0531-83129659 | shunjiang.yu@qilu-pharma.com | |
| Weijian Guo, Professor | Contact | 021-64175590 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Cancer Hospital | Shanghai | Shanghai Municipality | 2000 32 | China |
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| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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The first stage is a single-arm clinical trial, and the second stage is a controlled clinical trial.
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| Nab-paclitaxel | Drug | 100mg/m2, D1,8,15,Q4w, IV infusion |
|
| Paclitaxel | Drug | 80mg/m2, D1,8,15,Q4w, IV infusion |
|
Disease control rate(DCR)assessed by the investigators according to RECIST 1.1. |
| up to 2 years |
| Progression-free survival(PFS)assessed by the investigators according to RECIST 1.1(stage 1 and 2) | Progression-free survival(PFS)assessed by the investigators according to RECIST 1.1. | up to 2 years |
| Tumor response rate(TRR)assessed by the investigators according to RECIST 1.1(stage 1 and 2) | Tumor response rate(TRR)assessed by the investigators according to RECIST 1.1. | up to 2 years |
| Overall survival(stage 1) | Overall survival is defined as time from randomization to death due to any cause. | from the date of first dose until the date of death from any cause,assessed up to 2 years |
| Area under the concentration-time curve (AUC ) following single dose administration of PD-1(stage 1 ) | Area under the concentration-time curve (AUC ) following single dose administration of PD-1 | through study completion, an average of 2 years |
| Peak plasma concentration (Cmax) following single dose administration of PD-1(stage 1 ) | Peak plasma concentration (Cmax) following single dose administration of PD-1 | through study completion, an average of 2 years |
| Steady-state trough serum concentration of multiple Dose Administration of PD-1(stage 2) | Steady-state trough serum concentrationof multiple Dose Administration of PD-1 | through study completion, an average of 2 years |
| Steady-state peak serum concentration of multiple Dose Administration of PD-1(stage 2) | Steady-state peak serum concentration of multiple Dose Administration of PD-1 | through study completion, an average of 2 years |
| Immunogenicity(stage 1 and 2) | The titer of anti-drug antibodies (ADA)and neutralizing antibodies(Nab). | through study completion, an average of 2 years |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |