This is an open-label, single-arm phase 1b study to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of NTQ1062 in combination with Fulvestrant in patients with locally advanced or metastatic HR positive/HER-2 negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
Drug: NTQ1062 tablet(s) ,PO,QD in cycles of 28 days (21 days on treatment followed by 7 days off treatment). Drug: Fulvestrant Injection 500mg in a 28-day cycle.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGMaximum tolerated dose (MTD)
The MTD is defined as the highest dose reached for which the incidence of DLT occurs in less than 1/3 of the subjects.
Time frame: First treatment cycle ( 28 days)
Recommended phase 2 dose (RP2D)
RP2D will be determined using available safety and pharmacokinetics and pharmacodynamics data.
Time frame: Through study completion, an average of 1 year
Adverse events
Safety and tolerability of NTQ1062 in combination with Fluvastatin. Incidence of adverse events.
Time frame: Through study completion, an average of 1 year
Pharmacokinetic parameters: Cmax
Maximum Serum Concentration (Cmax) of NTQ1062 and NTQ1062-M.
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Pharmacokinetic parameters: Tmax
Time to Maximum Serum Concentration (Cmax) of NTQ1062 and NTQ1062-M.
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Pharmacokinetic parameters: AUC
The area under the concentration versus time curve of NTQ1062 and NTQ1062-M.
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Pharmacokinetic parameters: T1/2
The terminal half-life of NTQ1062 and NTQ1062-M.
Time frame: At the end of Cycle 3 (each cycle is 28 days)
Objective response rate (ORR)
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ORR is defined as participants with confirmed complete or partial response.
Time frame: Through study completion, an average of 1 year
Disease Control Rate (DCR)
DCR was defined as the proportion of patients who had an overall response of complete response (CR), partial response (PR), or stable disease (SD).
Time frame: Through study completion, an average of 1 year
Duration of Response (DOR)
DOR is defined as the time between date of first response and the first occurrence.
Time frame: Through study completion, an average of 1 year
Progression-free Survival (PFS)
PFS will be defined as the time between the first dose of any study drug and the first occurrence of progression or death from any cause.
Time frame: Through study completion, an average of 1 year