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The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors
This study is a prospective, single-arm, exploratory clinical trial. It plans to enroll patients with advanced solid tumors , treating them with HRS-4642 in combination with SHR-A2102. The entire study is divided into two stages: a safety run-in period and an efficacy exploration period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | SHR-A2102+HRS-4642 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102+HRS-4642 | Drug | A fixed dose was used for SHR-A2102,HRS-4642 can be dose adjusted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity(DLT) | one or more unacceptable toxic reactions that occur after administration, leading to an inability to further increase the dose or extend the dosing cycle. | At the end of Cycle 1 (each cycle is 14 days) |
| Objective Response Rate (ORR) | the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | the time from treatment initiation to the first disease progression or death from any cause | up to 2 year |
| Overall survival(OS) | the time from treatment initiation until death from any reason |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiming Wang, Professor | Contact | +8613783590691 | qimingwang1006@126.com | |
| Zhen He, Professor | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Qiming Wang, Professor | Henan Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Zhengzhou | Henan | China |
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| up to 2 year |
| Disease Control Rate (DCR) | the proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD) | up to 1 year |
| Duration of response (DoR) | Assessed by Investigator According to RECIST v1.1 | up to 1 year |
| Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory | Assess safety and tolerability by way of adverse events (CTCAE v5.0) | Begin from sign the ICF until the end of the safety follow-up period,Up to approximately 2 years. |