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The study is being conducted to evaluate the pharmacokinetics, radiation dosimetry, safety and preliminary efficacy of HRS-6768. To explore the reasonable dosage of HRS-6768 in the treatment of patients with advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-6768 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6768 | Drug | HRS-6768 |
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| Measure | Description | Time Frame |
|---|---|---|
| Phase 1:Dose-limiting toxicity (DLTs) | To evaluate the safety and tolerability of HRS-6768 and determine the RP2D. | From first dose of study drug through at least 6 weeks |
| Phase 1: recommended Phase 2 dose (RP2D) | To evaluate the safety and tolerability of HRS-6768 and determine the RP2D. | From first dose of study drug to end of phase 1 treatment (up to approximately 1 years) |
| Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768 | Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of HRS-6768 | From first dose of study drug to end of treatment (up to approximately 2 years) |
| Phase 2: Progression-free survival (PFS) | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1/2: Absorbed dose (Gy) estimated in organs and tumor lesions | To measure the radiation dosimetry of HRS-6768 | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Phase 1/2: Cmax of HRS-6768 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zengquan Gu | Contact | 0518-82342973 | zengquan.gu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Gaobo Hospital | Recruiting | Beijing | Beijing Municipality | 102206 | China |
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To evaluate the PK of HRS-6768 |
| From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Phase 1/2: Tmax of HRS-6768 | To evaluate the PK of HRS-6768 | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Phase 1/2: Area under the curve (AUC) of HRS-6768 | To evaluate the PK of HRS-6768 | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Phase 1/2: clearance (CL) of HRS-6768 | To evaluate the PK of HRS-6768 | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Phase 1/2: Objective Response Rate (ORR) | Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator. | From first dose of study drug until disease progression or end of treatment (up to approximately 1 years) |
| Phase 1/2: Duration of Response (DoR) | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Phase 1/2: Disease Control Rate (DCR) | Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) or CR or PR. | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Phase 1: Progression-free survival (PFS) | Progression-free survival (PFS) is defined as the time from the date of first dose to the date of first evidence of radiographic progression or death due to any cause, whichever occurred first. | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Phase 1/2: Overall Survival (OS) | Overall Survival (OS) is defined as the time from the date of first dose to the date of death due to any cause. | From first dose of study drug until disease progression or end of treatment (up to approximately 2 years) |
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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