AB122 Platform Study

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Pharmaceutical Co., Ltd.

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

917 Participants
are divided into 17 treatment groups

17

Treatment groups

See each treatment group below.

Sponsors and collaborators