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The study is being conducted to evaluate the safety, tolerability and pharmacokinetics of SHR-4685 in participants with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-4685 group | Experimental | Participants will receive SHR-4685 in different doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-4685 | Drug | SHR-4685, in different doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) of SHR-4685. | Up to 21 days. | |
| Maximum tolerated dose (MTD) of SHR-4685. | Up to 24 months. | |
| Recommended Phase II Dose (RP2D) of SHR-4685. | Up to 24 months. | |
| Adverse events (AEs). | From the first drug administration to within 30 days for the last treatment dose, up to 24 months. | |
| Serious adverse events (SAEs). | From the first drug administration to within 30 days for the last treatment dose, up to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The concentration of SHR-4685 in plasma will be determined. | Cmax will be derived. | At predefined intervals throughout the treatment period, up to 24 months. |
| Time to maximum concentration (Tmax). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yifan Shen, M.D | Contact | +86-0518-82342973 | yifan.shen.ys18@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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Single Group Assignment.
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Evaluation of pharmacokinetic parameter of SHR-4685.
| At predefined intervals throughout the treatment period, up to 24 months. |
| Area under the concentration-time curve from time 0 to time t (time of the last measurable concentration) (AUC0-t). | Evaluation of pharmacokinetic parameter of SHR-4685. The concentration of SHR-4685 in plasma will be determined. Area under the curve is the integral of the concentration-time curve. The AUC reflects the actual body exposure to drug after administration. The AUC is dependent on the rate of elimination of the drug from the body and the dose administered. | At predefined intervals throughout the treatment period, up to 24 months. |
| The concentration of Anti-SHR-4685 antibodies (ADA) in plasma will be determined. | At predefined intervals throughout the treatment period, up to 24 months. |
| Objective Response Rate (ORR). | Complete Response (CR) and Partial Response (PR) based on RECIST 1.1. | Up to 24 months. |
| Disease control rate (DCR). | Complete Response (CR), Partial Response (PR) and Stable Disease (SD) based on RECIST 1.1. | Up to 24 months. |
| Duration of response (DoR). | Time from documentation of tumor response to disease progression assessed among patients who had an objective response. | Up to 24 months. |
| Progression Free Survival (PFS). | Time from C1D1 to first assessment of disease progression or death, whichever is earlier. | Up to 24 months. |