This is a phase 1, non-randomized open-label, multicenter platform study designed to evaluate the tolerability and safety of AB122 in patients with malignancies specified in each cohort.
Is male or female aged ≥ 18 years at the time of informed consent; Willing and able to comply with scheduled visits and study procedures (except for Cohort E-2);
Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 before administration of study treatment;
T-Bil of ≤ 1.5 × ULN
ANC ≥ 1500 /mm3 (ie, ≥ 1.5 × 109 /L by International System of Units [SI]) (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF])
Clinically significant history or current evidence of cardiac arrhythmia and/or conduction abnormality: Any factor that can increase the risk of corrected QT interval (QTc) prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, etc.;
Major surgery within 4 weeks (the surgical incision should be fully healed prior to the day on which study treatment is scheduled to be started);
Extended-field radiotherapy within 4 weeks or limited-field radiotherapy within 2 weeks;
Any anticancer therapy within 2 weeks;
Single group
AB122
DrugAB122 will be administered with 360 mg/body given by infusion over 60 minutes Q3W.
AB122
DrugAB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.
TAS-116
DrugTAS-116 will be administered orally in 5-day on and 2-day off schedule on an empty stomach at least 1 hour before or 2 hour after eating.
TAS-120
DrugTAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.
TAS-115
DrugTAS-115 will be administered orally in 5-day on and 2-day off schedule on an empty stomach at least 1 hour before or 2 hours after eating.
TAS-102
DrugTAS-102 will be administered orally twice daily at a dose calculated based on body surface area (BSA) within 1 hour after morning and evening meals for 5 days, a week with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks.
Ramucirumab
DrugRamucirumab will be administered by infusion at a dose calculated using the body weight over approximately 60 minutes every 2 weeks.
TAS-102
DrugTAS-102 will be administered orally twice daily at a dose calculated based on BSA within 1 hour after morning and evening meals for 5 days, a week with 2 days rest for 2 weeks, followed by a 14-day rest, repeated every 4 weeks.
Bevacizumab
DrugBevacizumab will be administered by infusion at a dose calculated using the body weight over approximately 90 minutes every 2 weeks.
Fluorouracil
DrugFluorouracil will be administered with 800 mg/m2/day given by continuous intravenous infusion from Day 1 to Day 5.
Cisplatin
DrugCisplatin will be administered with 80 mg/m2 given by infusion every 3 weeks.
AB154
DrugAB154 will be administered with 1200 mg/body given by infusion over 60 minutes every 3 weeks.
Fluorouracil
DrugFluorouracil will be administered with 1000 mg/m2/day given by continuous intravenous infusion from Day 1 to Day 4.
Carboplatin
DrugCarboplatin will be administered with AUC 5 given by infusion every 3 weeks.
Cisplatin
DrugCisplatin will be administered with 100 mg/m2 given by infusion every 3 weeks.
Carboplatin
DrugCarboplatin will be administered with AUC 6 given by infusion every 3 weeks.
nab-Paclitaxel
DrugNab-Paclitaxel will be administered with 100 mg/m2 given by infusion on Day 1, Day 8 and Day 15.
Cisplatin
DrugCisplatin will be administered with 25 mg/m2 given by infusion on Day 1 and Day 8.
Gemcitabine
DrugGemcitabine will be administered with 1000 mg/m2 given by infusion on Day 1 and Day 8.
nab-Paclitaxel
DrugNab-Paclitaxel will be administered with 125 mg/m2 given by infusion on Day 1, Day 8 and Day 15.
Gemcitabine
DrugGemcitabine will be administered with 1000 mg/m2 given by infusion on Day 1, Day 8 and Day 15.
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Treatment groupsSee each treatment group below.
Phase 1a (All cohorts except Cohort D-4, D-5 and D-9) : Percentage of participants who experience a Dose Limiting Toxicity (DLT)
Phase 1a (Cohort D-4, D-5 and D-9) : Percentage of adverse events and treatment-related adverse events.
Phase 1b (Cohort B-n, D-n and E-n) : Objective Response Rate (ORR)
Phase 1b (Cohort C-n): The 6-month PFS proportion by RECIST v1.1
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