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A Phase 1, Open-Label Study to Evaluate the Effect of Food on the Pharmacokinetics of Zipalertinib (TAS6417 FE study)

TAS6417 FE study (TAS6417 FE study)

Hida Toyoaki

Central Japan International Medical Center

1-1 Health Town, Minokamo City

th-TAS6417-FE@taiho.co.jp

Matsubara Kana

Taiho Pharmaceutical Co., Ltd.

1-27 Kandanishiki-cho, Chiyoda-ku, Tokyo

+81-3-3294-4527

th-TAS6417-FE@taiho.co.jp

Recruiting

June. 05, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

crossover assignment

other

1. Provided written informed consent.
2. Is >= 18 years of age at the time of informed consent.
3. Histologically or cytologically confirmed locally advanced or metastatic nonsqauamous NSCLC, characterized at or after the time of locally advanced or metastatic disease diagnosis by EGFR mutation.
4. Refractory to prior therapies, unable to receive generally accepted standard therapies, or unwilling to receive such therapies.

1. Documented EGFR C797S mutation-positive status Histologically or cytologically confirmed locally advanced or metastatic nonsqauamous NSCLC
2. Have any unresolved toxicity of Grade >= 2 from previous anticancer treatment except for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable Grade 2 toxicities may be allowed to enroll after agreement between the investigator and Sponsor.
3. Have allergy to any components of the high-fat test meal.
4. Use tobacco products.

Both

EGFR-mutant NSCLC

Single-dose period
- Group A (Fasting-first administration group)
After fasting for 10 hours or more, Zipalertinib will be administered orally at a dose of 100 mg, and patients will continue fasting until 4 hours after dosing. Except at the time of study drug administration, water intake will be prohibited from 1 hour before until 1 hour after dosing. Following a washout period after the first single-dose administration and after fasting for 10 hours or more, patients will begin consumption of a high-fat test meal starting 30 minutes prior to the scheduled dosing time of zipalertinib, which must be completely consumed within 30 minutes. At the scheduled dosing time, zipalertinib will be administered orally at a dose of 100 mg, patients will continue fasting until 4 hours after dosing. Except at the time of study drug administration, water intake will be prohibited from 1 hour before until 1 hour after dosing.
- Group B (Fed-first administration group)
After fasting for 10 hours or more, patients will begin consumption of a high-fat test meal starting 30 minutes prior to the scheduled dosing time of zipalertinib, which must be completely consumed within 30 minutes. At the scheduled dosing time, zipalertinib will be administered orally at a dose of 100 mg, and patients will continue fasting until 4 hours after dosing. Except at the time of study drug administration, water intake will be prohibited from 1 hour before until 1 hour after dosing. Following a washout period after the first single-dose administration and after fasting for 10 hours or more, zipalertinib will be administered orally at a dose of 100 mg, and patients will continue fasting until 4 hours after dosing. Except at the time of study drug administration, water intake will be prohibited from 1 hour before until 1 hour after dosing.

Multiple-dose period
After completion of the single-dose period, the multiple-dose period will be initiated immediately. In principle, Cycle1 Day1 of the multiple-dose period will be defined as the day 48 hours after the second single-dose administration (Day5 of the single-dose period). Zipalertinib will be administered orally at a dose of 100 mg BID in cycles of 21 days until the criteria for discontinuation of the study drug are met.

PK parameters of zipalertinib (Cmax, AUClast, AUCinf)

+81-3-5050-4268

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