The goal of this clinical trial is to evaluate the safety and tolerability of AD1208 to determine the maximum tolerated dose(MTD) or maximumly administered dose(MAD) in any progressive, locally advanced (unresectable) or metastatic solid tumors. The main questions it aims to answer are: * Which dosage of AD1208 is safe and tolerable for participants? * What medical problems do participants have when taking AD1208? Participants will: * Take drug AD1208 every day up to 1 cycle at the least. * Visit the site once every 1 weeks for checkups and tests during cycle 1 and every 3 weeks from cycle 2 onwards. * Keep a diary of any adverse events and administrated drug
\- Dose-escalation Part The treatment cycle is defined as 21 days and AD1208 will be administered orally once or twice a day from Day 1 to Day 21 in every 21-day cycle. The dose-escalation part is divided into phase 1a, which determines the Recommended dose of AD1208 in monotherapy, and phase 1b, which determines the RP2D of AD1208 in combination therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Up to 6 of cohorts will be applied sequentially in phase Ia part.
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGSafety and tolerability
to determine maximum tolerated dose (MTD) or maximumly administered dose (MAD)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
Maximum Plasma Concentration [Cmax]
to characterize pharmacokinetic profile of AD1208
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
A trough level or trough concentration [Ctrough]
to characterize pharmacokinetic profile of AD1208
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Time to peak drug concentration [Tmax]
to characterize pharmacokinetic profile of AD1208
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Half-life [T1/2]
to characterize pharmacokinetic profile of AD1208
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
The area under the curve up to the last quantifiable time-point [AUC0-last]
to characterize pharmacokinetic profile of AD1208
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Clearance [CL]
to characterize pharmacokinetic profile of AD1208
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
Volume of distribution at steady state [Vss]
to characterize pharmacokinetic profile of AD1208
Time frame: At the Day 1 and Day 15 of Cycle 1 (each cycle is 21 days)
objective response rate [ORR]
to evaluate the preliminary antitumor activity
Time frame: through study completion, an average of 1 year
disease control rate [DCR]
to evaluate the preliminary antitumor activity
Time frame: through study completion, an average of 1 year
treatment duration
to evaluate the preliminary antitumor activity
Time frame: through study completion, an average of 1 year
progression-free survival [PFS]
to evaluate the preliminary antitumor activity
Time frame: through study completion, an average of 1 year
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