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The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in combination with SHR-1316 in patients with advanced malignancies and to provide a recommended dose (RP2D) for subsequent clinical studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-1501 and SHR-1316 dose escalation | Experimental | SHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously. |
|
| SHR-1501 and SHR-1316 dose expansion | Experimental | SHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously. |
|
| SHR-1501 and SHR-1316 Indication expansion | Experimental | SHR-1501 given subcutaneously with a recommended dose. SHR-1316 given intravenously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1501 | Drug | Administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity and Maximum tolerated dose | Dose-limiting toxicity and Maximum tolerated dose in patients with advanced tumors treated by SHR-1501 combined with SHR-1316. | Approximately 42 Days. |
| Recommended Phase 2 dose (RP2D) | Recommended Phase 2 dose (RP2D) based on comprehensive evaluation | Approximately 2 years |
| Adverse event/Serious adverse event | Incidence/severity of adverse events/serious adverse events (rated based on CTC AE v5.0) | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) | Single dose: maximum concentration (Cmax) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: time to maximum concentration (Tmax) |
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Inclusion Criteria:
• All Patients All patients must meet all the following criteria to be eligible to participate:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yilong Wu, MD | Guangdong General Hospital & Guangdong Academy of Medical Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydney Southwest Private Hospital | Liverpool | New South Wales | 2170 | Australia | ||
| Scientia Clinical Research |
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| SHR-1316 | Drug | Administered intravenously |
|
| Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: areas under the concentration-time curve (AUClast and AUCinf) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: half-life (t1/2) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: clearance (CL) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: mean residence time (MRT) | Approximately 2 years |
| Pharmacokinetic (PK) | Single dose: volume at steady state (Vss) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable): maximum concentration at steady state (Css_max) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable): time to maximum concentration (Tss_max) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable): area under the concentration-time curve at steady state (AUCss) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable): t1/2 | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable):steady-state minimum concentration at steady state (Css_min) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable): average concentration at steady state(Css_av) | Approximately 2 years |
| Pharmacokinetic (PK) | Multiple doses (at steady state, if applicable): accumulation ratio (Rac) | Approximately 2 years |
| Immune related features | indicated by the count of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points. | Approximately 2 years |
| Immune related features | indicated by the percentage of CD8+ T-lymphocytes in peripheral blood at scheduled post-dose time points. | Approximately 2 years |
| Immune related features | indicated by the count of natural killer (NK) cells in peripheral blood at scheduled post-dose time points. | Approximately 2 years |
| Immune related features | indicated by the percentage of natural killer (NK) cells in peripheral blood at scheduled post-dose time points. | Approximately 2 years |
| Objective response rate | Percentage of participants with CR or PR. | Approximately 2 years |
| Disease control rate | Percentage of participants with CR or PR or SD. | Approximately 2 years |
| Duration of response | Duration of time of tumor remission. | Approximately 2 years |
| progression-free survival | Progression-free survival time. | Approximately 2 years |
| 12 months overall survival | 12-month survival rate. | Approximately 2 years |
| Durable clinical benefit rate at 6 month | Percentage of participants with CR or PR or SD lasts over six months. | Approximately 2 years |
| Immunogenicity | The immunogenicity of SHR-1501 single drug and the immunogenicity of SHR-1316 combined with SHR-1501. The indicator includes number of participants with anti-drug antibody positive or neutralizing antibody positive. | Approximately 2 years |
| Randwick |
| New South Wales |
| 2031 |
| Australia |
| Icon Cancer Centre South Brisbane | South Brisbane | Queensland | 4101 | Australia |
| John Flynn Private Hospital | Tugun | Queensland | 4224 | Australia |
| Guangdong General Hospital & Guangdong Academy of Medical Sciences | Guangzhou | Guangdong | 510080 | China |