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This is a Phase I/II, multicenter, open-label clinical trial with dose escalation/dose expansion/efficacy expansion phases, designed to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic (PK/PD) profiles, and antitumor efficacy characteristics of HRS-6719 in patients with MTAP-deficient advanced solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-6719 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-6719 | Drug | HRS-6719 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Limited Toxicity (DLT) | 21 Days (first cycle) | |
| Maximum tolerable dose (MTD) | 21 Days (first cycle) | |
| Recommended dose for phase II (RP2D) | through phase I completion, an average of 1 years | |
| Incidence and severity of AE | from Day1 to 30 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Relative bioavailability after meals on an empty stomach | through phase I completion, an average of 1 years | |
| ORR | 12 months after the last subject was enrolled in the group | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shi Wei SUN | Contact | 18036618554 | Shiwei.sun@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| DOR |
| 12 months after the last subject was enrolled in the group |
| DCR | 12 months after the last subject was enrolled in the group |
| TTR | 12 months after the last subject was enrolled in the group |
| PFS | 12 months after the last subject was enrolled in the group |
| OS | 1 Year after last dose |
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
|