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This is an open label, phase 1 clinical study to evaluate the safety and tolerability of different doses of QLH11906 monotherapy in patients with relapsed/refractory, unresectable locally advanced or metastatic advanced solid tumors with abnormal MAPK pathway, and determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD, if MTD cannot be determined) and Recommended Dose in Phase II Clinical Studies (Recommended Phase II Dose, RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLH11906 | Experimental | QLH11906 Tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLH11906 | Drug | QLH11906 only |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD/MAD | The Maximum Tolerated Dose (MTD) will be determined during dose escalation using a Bayesian Optimal Interval (BOIN) design.The maximum administrated dose (MAD) is defined as the highest dose of all groups if MTD can not be determined. | Up to 24 approximately months |
| RP2D | Recommended dose for phase II trials | Up to 24 approximately months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) /Serious Adverse Events (SAEs) | Up to 24 approximately months | |
| Area under the concentration-time curve(AUC) | Pharmacokinetic (PK) parameters of QLH11906 monotherapy, including Area under the concentration-time curve(AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lianghua Fang | Contact | 86-13645192882 | lianghua.fang@qilu-pharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shandong Cancer Hospital | Recruiting | Shandong | China |
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| Up to 24 approximately months |
| Overall response rate (ORR) | The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria, including objective response rate(ORR). | Up to 24 approximately months |
| Duration of response (DoR) | The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria, including duration of response(DOR). | Up to 24 approximately months |
| Disease control rate (DCR) | The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria, including disease control rate(DCR). | Up to 24 approximately months |
| Maximum concentration (Cmax) | Pharmacokinetic (PK) of QLH11906 monotherapy, including Maximum concentration (Cmax) | Up to 24 approximately months |