This study is a multicenter, open-label, phase I/II study of YL205 in China to evaluate the safety, tolerability, PK characteristics and preliminary efficacy of YL205 in the following selected patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
252
YL205 is provided in the form of lyophilized powder under a strength of 160 mg/vial. Each vial should be reconstituted to 20 mg/mL. Prior to IV infusionSubjects will be treated with YL205 via intravenous (IV) infusion, once every 3 weeks (Q3W) as a treatment cycle
To evalue the DLTs
Time frame: Approximately within 36 months
To evalue the TEAEs
Treatment Emergent Adverse Event
Time frame: Approximately within 36 months
To evalue the TRAEs
Treatment Related Adverse Event
Time frame: Approximately within 36 months
To evalue the serious adverse events (SAEs)
Time frame: Approximately within 36 months
Determination of the MTD of YL205 in the pivotal clinical study
Time frame: Approximately within 36 months
Determination of the RED of YL205 in the pivotal clinical study
Time frame: Approximately within 36 months
Determination of the RP2D of YL205 in the pivotal clinical study
Time frame: Approximately within 36 months
Assessed ORR (the proportion of CR and PR) by the investigator per RECIST v1.1
Time frame: Approximately within 36 months
Characterize the PK parameter AUC
area under curve (AUC)
Time frame: Approximately within 36 months
Characterize the PK parameter Cmax
maximum concentration (Cmax)
Time frame: Approximately within 36 months
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Sarah Cannon Research Institute (SCRI)- Denver
Denver, Colorado, United States
RECRUITINGYale Cancer Center
New Haven, Connecticut, United States
RECRUITINGFlorida Cancer Specialists - Lake Mary
Lake Mary, Florida, United States
RECRUITINGNorton Cancer Institute
Louisville, Kentucky, United States
RECRUITINGWashington University School of Medicine - Center for advanced Medicine
St Louis, Missouri, United States
RECRUITINGComprehensive Cancer Centers of Nevada (CCCN) - Central Valley
Las Vegas, Nevada, United States
RECRUITINGSouthwest Women's Oncology
Albuquerque, New Mexico, United States
RECRUITINGStephenson Cancer Center (Oklahoma)
Oklahoma City, Oklahoma, United States
RECRUITINGProvidence Cancer Institute - Franz Clinic
Portland, Oregon, United States
RECRUITINGSarah Cannon Research (SCRI)-Tennessee
Nashville, Texas, United States
RECRUITING...and 33 more locations
Characterize the PK parameter Ctrough
minimum concentration at trough (Ctrough)
Time frame: Approximately within 36 months
Characterize the PK parameter Vd
volume of distribution (Vd)
Time frame: Approximately within 36 months
Characterize the PK parameter CL
plasma clearance (CL)
Time frame: Approximately within 36 months
Characterize the PK parameter Tmax
time to maximum concentration (Tmax)
Time frame: Approximately within 36 months
Characterize the PK parameter t1/2
half-life (t1/2)
Time frame: Approximately within 36 months
Assessed the disease control rate (DCR) per RECIST v1.1
(defined as the proportion of CR, PR, or stable disease (SD))
Time frame: Approximately within 36 months
Assessed the duration of response (DOR) per RECIST v1.1
Time frame: Approximately within 36 months
Assessed the time to response (TTR) per RECIST v1.1
Time frame: Approximately within 36 months
Assessed the progression free survival (PFS) per RECIST v1.1
Time frame: Approximately within 36 months
Assessed the depth of response (DpR) per RECIST v1.1
the percentage change in target lesion size
Time frame: Approximately within 36 months
Assessed the overall survival (OS) per RECIST v1.1
Time frame: Approximately within 36 months
Evaluate the corelaton between different levels of Napi2B expression and the sum of CR rate, PR rate and SD rate
Time frame: Approximately within 36 months