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The study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-7787 injection monotherapy for patients with advanced solid tumors. To explore the reasonable dosage of SHR-7787 injection monotherapy for patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group: SHR-7787 injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-7787 injection | Drug | Firstly Dose Escalation and Dose Expansion of SHR-7787 injection monotherapy should be conducted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose | The Maximum tolerated dose of SHR-7787 injection monotherapy | first dose of study medication up to 21 days |
| Recommended phase II dose | The Recommended phase II dose of SHR-7787 injection monotherapy | first dose of study medication up to 21 days |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | from signature completion of ICF to 60 days after the last dose or to the beginning of the new anti-cancer therapy, whichever came first, assessed up to 24 weeks |
| Incidence of Dose Limited Toxicity (DLT) | Incidence of Dose Limited Toxicity (DLT) described in the protocol | from first dose to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | PK parameters of single dose of SHR-7787 injection monotherapy | predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose |
| Cmax | PK parameters of single dose of SHR-7787 injection monotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ke Ma | Contact | +0518-81220121 | ke.ma@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
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SHR-7787 injection monotherapy
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| predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose |
| AUC0-t | PK parameters of single dose of SHR-7787 injection monotherapy | predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose |
| t1/2 | PK parameters of single dose of SHR-7787 injection monotherapy | predose, 8 h (hours), 24h, 48h, 72h, 168h post-dose |
| ADA | Anti-drug antibody, Immunogenicity of SHR-7787 in monotherapy | 0.5 hour before first dose through study completion, an average of 1 year |
| ORR | Objective Response Rate, Efficacy endpoints of SHR-7787 injection monotherapy in treatment of patients with advanced solid tumors | from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, death, lost to follow-up, voluntary withdrawal, or initiation of other anti-tumor treatment, whichever occurs first, assessed up to 6 months |