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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
QLH11906 only
Shandong Cancer Hospital
Shandong, China
RECRUITINGMTD/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.
Time frame: Up to 24 approximately months
RP2D
Recommended dose for phase II trials
Time frame: Up to 24 approximately months
Adverse Events (AEs) /Serious Adverse Events (SAEs)
Time frame: 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)
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: Up to 24 approximately months
Maximum concentration (Cmax)
Pharmacokinetic (PK) of QLH11906 monotherapy, including Maximum concentration (Cmax)
Time frame: Up to 24 approximately months
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