This is a Phase II, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of HG146 in participants with recurrent or metastatic adenoid cystic carcinoma. This study is divided into two stages. 40 participants will be enrolled in the first stage. The efficacy and safty data will apply to make go or no go decision. Then the second stage will continue to enroll 100 Particapants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
Shanghai Oriental Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGobjective response rate (ORR)
ORR will be assessed by the investigators using RECIST v1.1
Time frame: From enrollment to the end of treatment at 4 weeks
6 Months Progression-Free Survival (PFS)
PFS will be assessed by the investigators using RECIST v. 1.1
Time frame: From enrollment to treatment at 6 months.
Progression-Free Survival (PFS)
PFS will be assessed by the investigators using RECIST v1.1
Time frame: From enrollment to treatment at 12 months
Duration of response (DoR)
DOR will be assessed by the investigators using RECIST v1.1
Time frame: From enrollment to the end of treatment at 4 weeks
Disease control rate (DCR)
DCR will be assessed by the investigators using RECIST v1.1
Time frame: From enrollment to the end of treatment at 4 weeks
Overall survival (OS)
OS will be assessed by the investigators
Time frame: From enrollment to the end of treatment at 4 weeks
Time-to-response (TTR)
TTR will be assessed by the investigators using RECIST v1.1
Time frame: From enrollment to the end of treatment at 4 weeks
Population pharmacokinetics (PopPK)
PopPK will be detected to predict exposure level of HG146 in human body.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From Cycle1 Day7 to Day13, 21 days per cycle