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;
AST and ALT ≤ 3 × ULN; or if a patient with documented liver metastases, AST and ALT ≤ 5 × ULN
T-Bil of ≤ 1.5 × ULN
Disqualifiers
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
- AB122
- TAS-116
- AB122
- TAS-116
- AB122
- TAS-120
- AB122
- TAS-115
- AB122
- TAS-115
- AB122
- TAS-102
- Ramucirumab
- AB122
- TAS-102
- Bevacizumab
- AB122
- AB122
- TAS-120
- Fluorouracil
- Cisplatin
- AB122
- TAS-120
- AB154
- AB122
- TAS-120
- Fluorouracil
- Carboplatin
- Cisplatin
- AB122
- TAS-120
- AB154
- AB122
- TAS-120
- Carboplatin
- nab-Paclitaxel
- AB122
- TAS-120
- Cisplatin
- Gemcitabine
- AB122
- TAS-120
- nab-Paclitaxel
- Gemcitabine
Treatment groups
17
Treatment groupsSee each treatment group below.