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Sponsor R&D strategy adjustment
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The study is being conducted to evaluate the safety and tolerability of HRS2300 and combined with SHR-1316 or SHR-1701 or trametinib or Almonertinib.To Determine the maximum tolerated dose (MTD) and recommended Dose (RP2D) for HRS2300 monotherapy and combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
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| Treatment group B | Experimental |
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| Treatment group C | Experimental |
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| Treatment group D | Experimental |
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| Treatment group E | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS2300 | Drug | HRS2300 monotherapy |
| |
| HRS2300、 SHR-1316 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Dose limited toxicity(DLT) | Cycle 1( 4 weeks- monotherapy;3 weeks -combination) | |
| Number of participants with adverse events | up to 3 years; at least once per treatment cycle | |
| Determine RP2D of HRS2300 monotherapy and combination in patients with advanced malignancy | Enrolled sequentially from the initial dose of the trial, each subject received only one dose of the study drug and no other dose. The first subject of each dose should complete the first administration and be observed for 7 days before the other two subjects can be enrolled. After the DLT observation period of the last subject in each dose group has ended, the next dose increment can be entered. At the end of the dose escalation phase, the dose closest to the estimated toxicity probability of the target was selected as the MTD . At the end of the dose escalation, the SMC determined the RP2D based on the previous data. | through study completion,an average of 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310022 | China |
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HRS2300 monotherapy or combined with SHR-1316, SHR-1701, trametinib, and Almonertinib
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| Drug |
HRS2300 combined with SHR-1316 |
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| HRS2300、SHR-1701 | Drug | HRS2300 combined with SHR-1701 |
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| HRS2300、trametinib | Drug | HRS2300 combined with trametinib |
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| HRS2300、Almonertinib | Drug | HRS2300 combined with Almonertinib |
|