Phase 1 Open-label, multicenter, dose escalation, dose expansion study
This is an open-label, multicenter, Phase 1 clinical trial to evaluate the maximum tolerated dose, safety, pharmacokinetic/pharmacodynamic characteristics and preliminary anti-tumor activity of SB17170 when administered alone(1a) and co-administered with standard of care(1b) to patients with locally advanced or metastatic solid tumors who have failed standard of care. 1 cycle of treatment of this clinical trial is 21 days, and tumors are assessed every 2 cycles.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
SB17170 capsules, Oral administration 21days/cycle
Asan Medical Center
Seoul, South Korea
NOT_YET_RECRUITINGSeoul National University Hospital
Seoul, South Korea
NOT_YET_RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGSafety and tolerability of SB17170
Evaluate DLT to estimate the maximum tolerated dose (MTD), and determine a recommended Phase 2 dose (RP2D).
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Pharmacokinetic(Cmax)
Peak Plasma Concentration
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacokinetic(Tmax)
Time to Peak Plasma Concentration
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacokinetic(AUC)
Area under the plasma concentration versus time curve
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
The anti-tumor activity with RECIST v1.1
CT/MRI every 6 weeks
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 100weeks
Pharmacodynamics(TIL)
Tumor infiltrated lymphocyte in Tumor tissue
Time frame: At Day1 and D22 of Cycle 1 (each cycle is 21 days)
Pharmacodynamics(TAM)
Tumor Associated Macrophage at Tumor Tissue
Time frame: At Day1 and D21 of Cycle 1 (each cycle is 21 days)
Pharmacodynamics(T cell activation)
T cell activation in Blood
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Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(PD-L1)
PD-L1 in Blood and D1 of each cycle
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(High Mobility Group Box 1 )
HMGB1 in Blood and Tissue
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(S100A8)
S100A8 in Blood
Time frame: At Day1 and D21 of Cycle 1 t and D1 of each cycle (each cycle is 21 days)
Pharmacodynamics(S100A9)
S100A9 in Blood
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Pharmacodynamics(CXCL8)
CXCL8 in Blood
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)
Pharmacodynamics(MDSC)
Rate of Myeloid-Drived Suppressor Cell in Blood
Time frame: At Day1 and D21 of Cycle 1 and D1 of each cycle(each cycle is 21 days)