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An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Intravenous infusion, Once per treatment cycle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemay5087 | Drug | intravenous infusion,once every 3 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 3 weeks of treatment | |
| Incidence of dose-limiting toxicity (DLT) in each dose group | 3 weeks of treatment | |
| Maximum tolerated dose (MTD) or Maximum climbing dose (MAD) of Hemay181 | 3 weeks of treatment | |
| Subsequent recommended doses of Hemay181 | 3 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | 3 weeks of treatment | |
| Duration of Response | 3 weeks of treatment | |
| Disease Control Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| jingyi xu | Contact | 86-022-24899621 | xujingyi@hemay.com.cn |
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| 3 weeks of treatment |
| Time to Response | 3 weeks of treatment |
| Progression-Free Survival | 3 weeks of treatment |
| Maximum Plasma Concentration (Cmax) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Time to reach maximum concentration (Tmax) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Elimination half life(t1/2) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Plasma Clearance(CL) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Mean Residence Time from 0 to last time of quantifiable concentration(MRT 0-t) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Mean Residence Time from 0 to infinite time(MRT 0-∞) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Area under the plasma concentration-time curve from 0 to last time of quantifiable concentration(AUC 0-t) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Area under the plasma concentration-time curve from 0 extrapolated to infinite time(AUC 0-∞) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Percentage of the residual area (AUC%Extra) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Volume of distribution(Vz) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |
| Elimination rate constant(λz) | Pharmacokinetic (PK) profile | 0,0.75, 1.5, 1.75, 2, 2.5, 5.5, 9.5, 25.5, 49.5,121.5, 217.5, 313.5,481.5 hours post-dose on day 1, and 0,1.5, 2.5 hours post-dose on day 22 |