The purpose of this study is evaluate the efficacy of 3D185 in subjects with advanced/metastatic cholangiocarcinoma with FGFR2 Gene Alterations who have failed at least 1 previous treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
All eligible subjects will receive the RP2D regimen to be established based on the results of the ongoing phase I study from Cycle 1 Day 1 (C1D1) until disease progression, intolerable toxicity, withdrawal of consent, whichever occurs first.
ORR
defined as the proportion of subjects who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators.
Time frame: 24 months
Duration of response (DoR)
DoR is defined as the time from the date of first CR or PR based on RECIST v1.1 to the date of first documented progressive disease based on RECIST v1.1 or death, whichever occurs first.
Time frame: 24 months
Disease control rate (DCR)
defined as the proportion of subjects who achieve a confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST v1.1 as assessed by investigators.
Time frame: 24 months
Progression-free survival (PFS)
PFS is defined as the time from the date of first study dose to disease progression based on RECIST v1.1 or death, whichever occurs first.
Time frame: 24 months
Overall survival (OS)
OS is defined as the date of first study dose to the date of death from any cause.
Time frame: 24 months
3D185 Plasma concentration
The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures.
Time frame: 24 months
Serum phosphate levels
The pharmacokinetic and pharmacodynamics assessments will be analyzed descriptively and presented in appropriate tables or figures.
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Time frame: 24 months