RecruitingPhase 1NCT04999761

AB122 Platform Study

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


Sponsor

Taiho Pharmaceutical Co., Ltd.

Enrollment

917 participants

Start Date

Jun 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a drug called AB122 in people with various advanced cancers that have stopped responding to other treatments. It is a platform study, meaning it tests the drug in multiple cancer types at once. **You may be eligible if...** - You are 18 or older with advanced or metastatic cancer - Your cancer has progressed or you cannot tolerate standard treatments - Your general health is fairly good (ECOG performance status 0 or 1) - Your liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your organ function (liver, kidneys, blood) is too impaired - You are pregnant or breastfeeding - You have certain active infections or immune conditions that would make the treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAB122

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

DRUGAB122

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

DRUGTAS-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.

DRUGAB122

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

DRUGTAS-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.

DRUGAB122

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

DRUGTAS-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.

DRUGAB122

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

DRUGTAS-120

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

DRUGAB122

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

DRUGTAS-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.

DRUGAB122

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

DRUGTAS-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.

DRUGAB122

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

DRUGTAS-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.

DRUGRamucirumab

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

DRUGAB122

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

DRUGTAS-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.

DRUGBevacizumab

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

DRUGAB122

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

DRUGAB122

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

DRUGTAS-120

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

DRUGFluorouracil

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

DRUGCisplatin

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

DRUGAB122

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

DRUGTAS-120

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

DRUGAB154

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

DRUGAB122

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

DRUGTAS-120

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

DRUGFluorouracil

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

DRUGCarboplatin

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

DRUGCisplatin

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

DRUGAB122

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

DRUGTAS-120

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

DRUGAB154

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

DRUGAB122

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

DRUGTAS-120

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

DRUGCarboplatin

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

DRUGnab-Paclitaxel

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

DRUGAB122

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

DRUGTAS-120

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

DRUGCisplatin

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

DRUGGemcitabine

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

DRUGAB122

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

DRUGTAS-120

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

DRUGnab-Paclitaxel

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

DRUGGemcitabine

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


Locations(9)

A site selected by Taiho Pharmaceutical Co., Ltd.

Aichi, Japan

A site selected by Taiho Pharmaceutical Co., Ltd.

Chiba, Japan

A site selected by Taiho Pharmaceutical Co., Ltd.

Ehime, Japan

A site selected by Taiho Pharmaceutical Co., Ltd.

Hokkaido, Japan

A site selected by Taiho Pharmaceutical Co., Ltd.

Kanagawa, Japan

A site selected by Taiho Pharmaceutical Co., Ltd.

Osaka, Japan

A site selected by Taiho Pharmaceutical Co., Ltd.

Shizuoka, Japan

A site selected by Taiho Pharmaceutical Co., Ltd.

Tokyo, Japan

A site selected by Taiho Pharmaceutical Co., Ltd.

Wakayama, Japan

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NCT04999761


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