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This study is an open, multicenter, dose-increasing/dose-expanding/efficacy expanding Phase I clinical study aimed at evaluating the tolerance, safety, PK, PD, and immunogenicity of SHR-5495 in the treatment of advanced malignant tumor patients, and preliminarily observing its anti-tumor efficacy. The entire study was divided into three stages: dose escalation, dose extension, and efficacy extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-5495 for injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-5495 for injection | Drug | SHR-5495 for injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limited toxicity (DLT) of SHR-5495 | up to 21 days | |
| AEs+SAEs | from the first drug administration to within 90 days for the last treatment dose | |
| Maximum tolerated dose(MTD)of SHR-5495 | up to 21 days | |
| Maximum administrated dose(MAD)of SHR-5495 | up to 21 days | |
| Recommended Phase II Dose (RP2D) of SHR-5495 | up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pharmacokinetic parameter of SHR-5495: Cmax | 12 months | |
| Evaluation of pharmacokinetic parameter of SHR-5495: Tmax | 12 months | |
| Evaluation of pharmacokinetic parameter of SHR-5495: AUClast |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Song | Contact | +86-0518-81220121 | li.song@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong First Medical University Affiliated Cancer Hospital | Recruiting | Jinan | Shandong | 250117 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| 12 months |
| Evaluation of pharmacokinetic parameter of SHR-5495: AUCinf | 12 months |
| Evaluation of pharmacokinetic parameter of SHR-5495: t1/2 | 12 months |
| Evaluation of pharmacokinetic parameter of SHR-5495: CL | 12 months |
| Evaluation of pharmacokinetic parameter of SHR-5495: Vss | 12 months |
| Receptor occupancy rate | 12 months |
| Objective Response Rate (ORR) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months |
| Duration of response (DoR) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months |
| Disease control rate (DCR) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months |
| Progression free survival(PFS) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months |
| Overall survival (OS) | From date of administration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months |
| Target cell count | 12 months |