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This study is a multi center, open label, dose increasing/dose expanding/efficacy expanding phase I clinical trial aimed at evaluating the safety, tolerance, PK characteristics, and anti-tumor efficacy characteristics of HRS-2189 single drug in patients with advanced malignant solid tumors. This study was divided into three stages: dose escalation, dose expansion, and efficacy expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-2189 Tablets | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2189 Tablets | Drug | HRS-2189 Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| AEs+SAEs | from the first drug administration to within 30 days for the last treatment dose | |
| Dose limited toxicity (DLT) of HRS-2189 | up to 35 days | |
| Maximum tolerated dose(MTD)of HRS-2189 | up to 35 days | |
| Recommended Phase II Dose (RP2D) of HRS-2189 | up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pharmacokinetic parameter of HRS-2189: Cmax | 2 months | |
| Evaluation of pharmacokinetic parameter of HRS-2189: Tmax | 2 months | |
| Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-t |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xia Zhang | Contact | +86-0518-81220121 | xia.zhang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150081 | China |
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| 2 months |
| Evaluation of pharmacokinetic parameter of HRS-2189: AUC0-inf | 2 months |
| Evaluation of pharmacokinetic parameter of HRS-2189: Cmax,ss | 2 months |
| Evaluation of pharmacokinetic parameter of HRS-2189: Tmax,ss | 2 months |
| Evaluation of pharmacokinetic parameter of HRS-2189: Cmin,ss | 2 months |
| Evaluation of pharmacokinetic parameter of HRS-2189: AUCss | 2 months |
| Evaluation of pharmacokinetic parameter of HRS-2189: Rac | 2 months |
| Bioavailability of HRS-2189 on an empty stomach and after meals | up to 9 days |
| Objective Response Rate (ORR) | Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) for target lesions assessed by CT or MRI | every 8 weeks since Day 8 administration,an average of 1 year |
| Duration of response (DoR) | Time from documentation of tumor response to disease progression assessed among patients who had an objective response | every 8 weeks since Day 8 administration,an average of 1 year |
| Disease control rate (DCR) | Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1 | every 8 weeks since Day 8 administration,an average of 1 year |
| Progression free survival(PFS) | The time from enrollment to the progression of tumors (in any aspect) or death (for any reason) | every 8 weeks since Day 8 administration,an average of 1 year |