The purpose of this study is evaluate the the safety, tolerability, pharmacokinetics profiles, and preliminary efficacy of 3D011-08 in subjects with advanced solid tumors.
Detailed Description: This study was initiated on February 24, 2022, at Fudan Cancer Hospital. However, noparticipants were screened or enrolled after the initiation. Due to strategic development adjustments, thecompany terminated the study on September 11. 2023.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
participants will receive 15mg (starting dose)intravenous drop of 3D011-08,All subjects in each cohort will receive a single dose of 3D011-08 first, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive doses on 1,3,5day of each week (28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first.Dose of the study medication will be escalated sequentially till the dose limiting toxicity is achieved to determine the recommended part 2 doses (RPTD).
Fudan University Shanghai Cancer Center
Shanghai, Floor 2, Building 2, 270 Dong 'an Road, Xuhui District, China
Maximum Tolerated Dose (MTD) of3D011-08
The maximum tolerated dose as determined in Part 1 of the study will be used as the recommended dose for Part 2.
Time frame: 24 months
ORR
proportion of subjects in cohort 1 and cohort 2 who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators.
Time frame: 24 Months
TTP
time to progression based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) as assessed by investigators .
Time frame: 24 Months
RPTD
RP2D will be determined based on pharmacodynamics or clinical response, as well as the incidence rate and nature of the toxicities observed.
Time frame: 24 months
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Time frame: 24 months
Cmax Cmax
Time frame: 24 months
Css min
Time frame: 24 months
Tmax
Time frame: 24 months
AUC0~t、AUC0~∞
Time frame: 24 months
Ctrough
Time frame: 24 months
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t1/2
Time frame: 24 months
CL
Time frame: 24 months
Vd
Time frame: 24 months
ORR
proportion of subjects in part of Dose Escalation who achieved a confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 as assessed by investigators.proportion of subjects in dose expansion cohort 3 who achieved a confirmed complete response (CR) or partial response (PR) based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) 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.part1 Dose Escalation,part 2 dose expansion:Cohort 1 and Cohort 2.
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.Proportion of subjects in dose expansion cohort 3 who achieve a confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) 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. Subjects in dose expansion cohort 3 based on the PCWG3 recommendations for assessment of prostate cancer disease progression (CT/MRI, bone scan) as assessed by investigators .
Time frame: 24 months
Permeable surface area of capillary wall(PS)
Time frame: 24 months
the incremental Area Under Curve (iAUC)
Time frame: 24 months