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The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Single Arm : SHR-A1904 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1904 | Drug | Single Arm :It is a dose-escalation and dose-expansion study of SHR-A1904 in subjects with advanced solid tumors |
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| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | DLT is defined during the first cycle of the study treatment and assessed as certainly or at least possibly related to SHR-A1904 treatment. | The first cycle of administration, up to 21 days. |
| Maximum tolerated dose (MTD) | MTD is defined as the dose with the estimated toxicity probability which is the closest to the target toxicity probability. | The first cycle of administration, up to 21 days. |
| Recommended Phase 2 Dose (RP2D) | RP2D is the dose selected for further study based on the phase I study results. | The first cycle of administration, up to 21 days. |
| Adverse events (AEs) and serious adverse events (SAEs) | From the signing of informed consent form to the end of safety follow-up period (90 days after the last dose). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | The proportion of efficacy evaluable subjects with the best overall response (BOR) of CR or PR as per RECIST 1.1 criteria. | Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject, currently estimated March 2026. |
| Duration of response (DoR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Chao | Contact | +41 79 47 68 792 | bo.chao@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Comprehensive Cancer Center | Active, not recruiting | Miami Beach | Florida | 33140 | United States | |
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SHR-A1904 in Subjects with Advanced Solid tumors
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DoR is defined as the time from first documented tumor response (CR/PR) until PD/death. |
| Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject. |
| Clinical benefit rate (CBR) | CBR is defined as the percentage of subjects who have achieved complete response (CR), partial response (PR) and/or stable disease (SD) lasting over 24 weeks (CR+PR+SD≥24 weeks). | Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject. |
| Progression-free survival (PFS) | PFS is defined as the time from the first dose until PD/death. | Evaluated until the end of study, approximately 12 months after the first dose of study drug of the last subject. |
| Overall survival (OS) | OS is defined as the time from first dose of study drug until death from any cause. | Until the end of study, approximately 12 months after the first dose of study drug of the last subject. |
| Time to maximum concentration (Tmax) | Up to 30 days after the last dose. |
| Maximum concentration (Cmax) | Up to 30 days after the last dose. |
| Comprehensive Hematology Oncology |
| Terminated |
| St. Petersburg |
| Florida |
| 33709 |
| United States |
| LSU Health Sciences Center | Active, not recruiting | New Orleans | Louisiana | 70112 | United States |
| University Hospitals Cleveland Medical Center | Terminated | Cleveland | Ohio | 44106 | United States |
| Rhode Island Hospital | Terminated | Providence | Rhode Island | 02905 | United States |
| Prisma Health | Active, not recruiting | Greenville | South Carolina | 29605 | United States |
| The University of Texas MD Anderson Cancer Center | Active, not recruiting | Houston | Texas | 77030 | United States |
| Central Coast Local Health District | Completed | Gosford | New South Wales | 2250 | Australia |
| Sydney South West Private Hospital | Completed | Liverpool | New South Wales | Australia |
| Scientia Clinical Research Ltd | Completed | Randwick | New South Wales | 2031 | Australia |
| Genesis Care North Shore | Completed | St Leonards | New South Wales | 2065 | Australia |
| Macquarie University | Completed | Sydney | New South Wales | 2109 | Australia |
| Westmead Hospital | Completed | Westmead | New South Wales | 2145 | Australia |
| Gold Coast Private Hospital | Completed | Southport | Queensland | 4215 | Australia |
| Peninsula and South Eastern Haematology & Oncology Group (PASO) | Completed | Frankston | Victoria | 3199 | Australia |
| One Clinical Research (OCR) | Completed | Nedlands | Western Australia | 8000 | Australia |
| National Institute of Oncology, Arensia Research Clinic | Active, not recruiting | Chisinau | MD-2000 | Moldova |
| Dong-A University Hospital | Recruiting | Busan | 49201 | South Korea |
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| Chungbuk National University Hospital | Recruiting | Cheongju-si | 28644 | South Korea |
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| Ajou University Hospital | Recruiting | Gyeonggi-do | 16499 | South Korea |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam | KS009 | South Korea |
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| CHA Bundang Medical Centre | Recruiting | Seongnam-si | 13496 | South Korea |
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| Korea University Anam Hospital | Recruiting | Seoul | 02841 | South Korea |
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| Korea University Guro Hospital | Recruiting | Seoul | 02841 | South Korea |
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| Severance Hospital, Yonsei University Health System | Recruiting | Seoul | 03722 | South Korea |
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| Asan Medical Center | Recruiting | Seoul | 05505 | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | 06531 | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | 3080 | South Korea |
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