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
Male or female subjects ≥19 years of age
Willing to consent to participate in study and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures
Histologically and/or cytologically confirmed any progressive, locally advanced (unresectable), or metastatic solid tumors that have relapsed or are refractory following the last line of treatment and for which prior standard therapy has been ineffective, standard therapy does not exist or is not considered appropriate.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Untreated active brain metastases.
has leptomeningeal disease.
unrecovered > Grade 1 from the adverse event of prior therapy except for alopecia.
has an active autoimmune disease requiring systemic treatment within the past 2 years.
Sequential
AD1208
DrugUp to 6 of cohorts will be applied sequentially in phase Ia part.
6
Treatment groupsSee each treatment group below.
Safety and tolerability
to determine maximum tolerated dose (MTD) or maximumly administered dose (MAD)
Maximum Plasma Concentration [Cmax]
to characterize pharmacokinetic profile of AD1208
A trough level or trough concentration [Ctrough]
to characterize pharmacokinetic profile of AD1208
Time to peak drug concentration [Tmax]
to characterize pharmacokinetic profile of AD1208
Half-life [T1/2]
to characterize pharmacokinetic profile of AD1208
metabolite 6 [M6]
to profile the metabolites of AD1208
metabolite 8 [M8]
to profile the metabolites of AD1208
metabolite 9 [M9]
to profile the metabolites of AD1208
metabolite 10 [M10]
to profile the metabolites of AD1208
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