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This is a phase Ia clinical study evaluating H1710 for Injection in Participants with advanced solid tumors.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of H1710 for Injection in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| H1710 for Injection | Experimental | Participants receive H1710 for Injection according to the protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H1710 for Injection | Drug | Injection. |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment-emergent adverse events | Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0 | Up to ~ 18 months |
| Dose Limiting Toxicities(DLT) | Up to ~ 18 months | |
| Maximum Tolerated Dose (MTD) | Up to ~ 18 months | |
| Recommended Phase 2 Dose (RP2D) | Up to ~ 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration(Cmax) of H1710 | Blood samples will be collected to determine the Cmax of H1710. | Up to ~ 18 months |
| Time of Maximum Concentration (Tmax)of H1710 | Time to reach H1710 maximum observed concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Province Hospital | Not yet recruiting | Nanjing | Jiangsu | 210029 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Up to ~ 18 months |
| Area Under the Concentration (AUC) of H1710 | Blood samples will be collected to determine the AUC of H1710. | Up to ~ 18 months |
| Terminal Half life( t½) of H1710 | Blood samples will be collected to determine the terminal half-life of H1710. | Up to ~ 18 months |
| Clearance (CL) of H1710 | Blood samples will be collected to determine the CL of H1710. | Up to ~ 18 months |
| Objective Response Rate (ORR) | Percentage of participants with best response of complete response (CR) or partial response (PR). | Up to ~ 18 months |
| Disease Control Rate(DCR) | The proportion of participants with best overall response of complete response(CR) or partial response(PR) or disease stabilization(SD) after treatment. | Up to ~ 18 months |
| Duration of Response (DOR) | Time from complete response(CR) or partial response(PR) to objective disease progression or death to any cause. | Up to ~ 18 months] |
| Progression Free Survival (PFS) | The time from the start of the treatment until objective disease progression or death from any cause. | Up to ~ 18 months |
| Beijing Cancer Hospital | Recruiting | Beijing | 100142 | China |
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| Peking University Shougang Hospital | Recruiting | Beijing | 100144 | China |
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| Shanghai East Hospital | Recruiting | Shanghai | China |
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