AB122 Platform Study

Summary

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.

Conditions

• Advanced or Metastatic Solid Tumor
• Pancreatic Ductal Adenocarcinoma
• Colorectal Cancer
• Non-small Cell Lung Cancer
• Gastric Cancer
• Alveolar Soft Part Sarcoma
• Esophageal Cancer
• Head and Neck Cancer
• Biliary Tract Cancer

Interventions

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes Q3W.

DRUG

AB122

AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.

DRUG

TAS-116

TAS-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.

DRUG

AB122

AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.

DRUG

TAS-116

TAS-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.

DRUG

AB122

AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.

DRUG

TAS-116

TAS-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.

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

TAS-120

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

TAS-115

TAS-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.

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

TAS-115

TAS-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.

DRUG

AB122

AB122 will be administered with 240 mg/body given by infusion over 60 minutes every 2 weeks.

DRUG

TAS-102

TAS-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.

DRUG

Ramucirumab

Ramucirumab will be administered by infusion at a dose calculated using the body weight over approximately 60 minutes every 2 weeks.

DRUG

AB122

AB122 will be administered with 240 mg/body given by infusion over 60 minutes every 2 weeks.

DRUG

TAS-102

TAS-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.

DRUG

Bevacizumab

Bevacizumab will be administered by infusion at a dose calculated using the body weight over approximately 90 minutes every 2 weeks.

DRUG

AB122

AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

TAS-120

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

DRUG

Fluorouracil

Fluorouracil will be administered with 800 mg/m2/day given by continuous intravenous infusion from Day 1 to Day 5.

DRUG

Cisplatin

Cisplatin will be administered with 80 mg/m2 given by infusion every 3 weeks.

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

TAS-120

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

DRUG

AB154

AB154 will be administered with 1200 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

TAS-120

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

DRUG

Fluorouracil

Fluorouracil will be administered with 1000 mg/m2/day given by continuous intravenous infusion from Day 1 to Day 4.

DRUG

Carboplatin

Carboplatin will be administered with AUC 5 given by infusion every 3 weeks.

DRUG

Cisplatin

Cisplatin will be administered with 100 mg/m2 given by infusion every 3 weeks.

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

TAS-120

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

DRUG

AB154

AB154 will be administered with 1200 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

TAS-120

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

DRUG

Carboplatin

Carboplatin will be administered with AUC 6 given by infusion every 3 weeks.

DRUG

nab-Paclitaxel

Nab-Paclitaxel will be administered with 100 mg/m2 given by infusion on Day 1, Day 8 and Day 15.

DRUG

AB122

AB122 will be administered with 360 mg/body given by infusion over 60 minutes every 3 weeks.

DRUG

TAS-120

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

DRUG

Cisplatin

Cisplatin will be administered with 25 mg/m2 given by infusion on Day 1 and Day 8.

DRUG

Gemcitabine

Gemcitabine will be administered with 1000 mg/m2 given by infusion on Day 1 and Day 8.

DRUG

AB122

AB122 will be administered with 240 mg/body given by infusion over 60 minutes every 2 weeks.

DRUG

TAS-120

TAS-120 will be administered orally once daily (QD) on an empty stomach at least 1 hour before or 2 hours after eating.

DRUG

nab-Paclitaxel

Nab-Paclitaxel will be administered with 125 mg/m2 given by infusion on Day 1, Day 8 and Day 15.

DRUG

Gemcitabine

Gemcitabine will be administered with 1000 mg/m2 given by infusion on Day 1, Day 8 and Day 15.

Sponsors & Collaborators

• Taiho Pharmaceutical Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Taiho Pharmaceutical Co., Ltd. · Taiho Pharmaceutical Co., Ltd.

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-01

Primary Completion

2026-05-31

Completion

2026-05-31

Countries

• Japan

Study Locations