NCT04999761

AB122 Platform Study

Platform Study of AB122 Based Treatments in Patients with Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 917 (estimated)
• Sponsor: Taiho Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2021-08-11
• Last updated: 2024-09-25

Locations

9 sites across 1 country: Japan