The purpose of the present study is to determine the safety, tolerability, and efficacy of WM-A1-3389 in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Anti-IGSF1 (Immunoglobulin superfamily member 1)
Anti-PD-1(Programmed cell death protein 1)
Seoul St. Mary's Hospital
Seoul, Seocho-gu, South Korea
RECRUITINGIncheon St. Mary's Hospital
Incheon, Yeonsu-gu, South Korea
RECRUITINGIncidence of Dose Limit Toxicities (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Number of Participants Who Experienced an Adverse Event (AE)
Time frame: Up to 6 Cycles (18 weeks)
Frequency of dose discontinuation and dose reduction due to ADRs
Time frame: Up to 6 Cycles (18 weeks)
Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumor (RECIST) v1.1
Time frame: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)
Disease control rate (DCR) based on RECIST v1.1
Time frame: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)
Disease control rate (DCR) based on Immune RECIST (iRECIST)
Time frame: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)
Duration of response (DOR) based on RECIST v1.1
Time frame: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)
Duration of response (DOR) based on iRECIST
Time frame: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)
Overall survival (OS)
Time frame: every 12 weeks after EOT (18 weeks)
Progression free survival (PFS) based on RECIST v1.1
Time frame: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)
Progression free survival (PFS) based on iRECIST
Time frame: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)
Target tumor size
Maximum rate of change in the sum of the maximum length of the target lesion For target tumor size, the number of subjects, average, standard deviation, median, minimum, and maximum values by each dosing group are presented.
Time frame: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)
Time to progression (TTP), time to response (TTR), time to failure (TTF), and other assessable efficacy endpoints
Time frame: Screening, Subsequent Cycles (every 6 weeks), EOT (up to 18 weeks)
Maximum Concentration (Cmax) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Maximum Concentration at steady state (Cmax,ss) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Minimum Concentration (Cmin) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Minimum Concentration at steady state (Cmin,ss) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Average Concentration at steady state (Cav,ss) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Area under the curve (AUC) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Area under the curve (AUC) from 0 to infinity of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Time to maximum concentration of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Time to maximum concentration at steady state of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Half life of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Peak trough fluctuation (PTF) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Accumulation ratio (AR) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Clearance rate (CL) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Volume of distribution (Vz) of WM-A1-3389 or WM-A1-3389 with Pembrolizumab
Time frame: Cycle 1, Cycle 2, Subsequent Cycles up to EOT (up to 18 weeks)
Number of participants with anti-WM-A1-3389 antibodies (Stage 1 only)
Time frame: Up to EOT (up to 18 weeks)
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