About this trial
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.
Eligibility criteria
Qualifiers
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])
Disqualifiers
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;
Trial design
Treatments tested in this trial
- AB122
- AB122
- TAS-116
- TAS-120
- TAS-115
- TAS-102
- Ramucirumab
- TAS-102
- Bevacizumab
- Fluorouracil
- Cisplatin
- AB154
- Fluorouracil
- Carboplatin
- Cisplatin
- Carboplatin
- nab-Paclitaxel
- Cisplatin
- Gemcitabine
- nab-Paclitaxel
- Gemcitabine
Treatment groups
18
Treatment groupsSee each treatment group below.