RecruitingPhase 1

AB122 Platform Study

Japan917 participantsStarted 2021-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. WOCBP patients: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;
. Male patients with WOCBP partners: during the clinical study and until 100 days after the last dose of AB122, 180 days after TAS-116, TAS-102, TAS-120 or TAS-115, whichever is later;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1a (All cohorts except Cohort D-4 and D-5) : Percentage of participants who experience a Dose Limiting Toxicity (DLT)

Timeframe: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q2W arm)

Phase 1a (Cohort D-4 and D-5) : Percentage of adverse events and treatment-related adverse events.

Timeframe: From first study treatment administration through Day 21 (Q3W arm) or Day 28 (Q2W arm)

Phase 1b (Cohort B-n, D-n and E-n) : Objective Response Rate (ORR)

Timeframe: Through completion of treatment (estimated up to be 11 months)

Phase 1b (Cohort C-n): The 6-month PFS proportion by RECIST v1.1

Timeframe: Through completion of treatment (estimated up to be 11 months)

Trial details

NCT IDNCT04999761

SponsorTaiho Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Drug Information Center

+81-3-3294-4527 toiawase@taiho.co.jp

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