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This study aims to evaluate the safety and tolerability of HRS-7058 combined with antitumor drugs in subjects with solid tumors, and to determine the recommended dosage for Phase II. Evaluate the objective response rate of HRS-7058 in combination with anti-tumor drugs in subjects with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-7058 | Experimental | HRS-7058 combined with antitumor drugs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-7058 | Drug | HRS-7058 combined with antitumor drugs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of dose-limiting toxicities (DLT). | About 28 days. | |
| The incidence and severity of adverse events (AEs). | According to NCI-CTCAE v5.0 standards. | About 28 days. |
| Recommended Phase 2 Dose (RP2D) of HRS-7058 in combination with antitumor drugs in subjects with solid tumors. | From the first dose to the last visit, about 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The duration of response (DoR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs. | From the first dose to the last visit, about 12 months. | |
| The objective response rate (ORR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengjin Zhang | Contact | +86-0518-82342973 | zhengjin.zhang.zz79@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| From the first dose to the last visit, about 12 months. |
| The disease control rate (DCR) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs. | From the first dose to the last visit, about 12 months. |
| The progression-free survival (PFS) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs. | From the first dose to the last visit, about 12 months. |
| The overall survival (OS) evaluated by researchers in participants with solid tumors using HRS-7058 in combination with antitumor drugs. | From the first dose to the last visit, about 12 months. |
| The blood concentration of HRS-7058 and SHR-1826. | From the first dose to the last visit, about 12 months. |
| Anti-drug antibodies (ADA). | Evaluation of the immunogenicity. | From the first dose to the last visit, about 12 months. |
| Neutralizing antibodies (NAb). | Evaluation of the immunogenicity. | From the first dose to the last visit, about 12 months. |