Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To assess the safety and tolerability of SHR-A1921 in patients with advanced solid tumours, to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and/or recommended phase II dose (RP2D) of SHR-A1921
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group: SHR-A1921 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A1921 | Drug | Treatment group: Subjects will receive an intravenous infusion of SHR-A1921 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity (DLT) | 21 Days (first cycle) | |
| Maximum Tolerable Dose (MTD) | 21 Days (first cycle) | |
| Recommended phase II dose (RP2D) | Screening up to dose escalation and expansion study completion, appropriately to 1 year | |
| Adverse Events | Incidence and grade of adverse events as assessed by CTCAE v5.0 | Screening up to study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum concentration (Tmax) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year | |
| Maximum concentration (Cmax) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quanren Wang, Ph.D | Contact | 86-021-61053363 | quanren.wang@hengrui.com | |
| Di Zong, MS | Contact | 86-010-67166319 | di.zong@hengrui.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Area under the concentration-time curve from time zero to the time of the last quantifiable time point t (AUC0-t) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
| Area under the concentration-time curve from time 0 extrapolated to infinity (AUC0-t) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
| Terminal half-life (t1/2) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
| Total body clearance (CL) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
| Volume of distribution at steady state (Vss) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
| Mean residence time (MRT) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
| Maximum steady-state drug concentration during a dosage interval (Css, max) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
| Minimum steady-state drug concentration during a dosage interval (Css, min) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
| Accumulation ratio (Rac) of SHR-A1921、total antibody | Screening up to end of treatment, an average of 1 year |
| Anti-drug antibody(ADA) level of SHR-A1921 | Screening up to 90 days after the last dose, an average of 1 year |
| Objective Response Rate (ORR) assessed by site investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Duration of Response (DoR) assessed by site investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Disease Control Rate (DCR) assessed by site investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Progression-Free Survival (PFS) assessed by site investigator as per RECIST 1.1 | Screening up to study completion, an average of 1 year |
| Overall Survival (OS) | Screening up to study completion, an average of 1 year |