TAS0728

P1/2, N=19, Terminated, Taiho Oncology, Inc. | Active, not recruiting --> Terminated; The study was stopped due to unacceptable toxicity during the dose-escalation portion (Phase 1) of the study and did not progress to Phase 2

P1/2, N=19, Active, not recruiting, Taiho Oncology, Inc. | Trial completion date: Dec 2021 --> Jun 2022 | Trial primary completion date: Dec 2021 --> Jun 2022

P1/2, N=19, Active, not recruiting, Taiho Oncology, Inc. | Trial completion date: Aug 2021 --> Dec 2021 | Trial primary completion date: Aug 2021 --> Dec 2021

The study was stopped due to unacceptable toxicity during the dose-escalation as the overall risk-benefit ratio no longer favored the dose level being tested, therefore the MTD was not determined. ClinicalTrials.gov registration number: https://clinicaltrials.gov/ct2/show/NCT03410927 ; registered on January 25, 2018.

P1/2, N=19, Active, not recruiting, Taiho Oncology, Inc. | Trial completion date: Jun 2020 --> Jan 2021 | Trial primary completion date: Jun 2020 --> Jan 2021

HER2-targeting antibodies (trastuzumab, pertuzumab) and a HER2-directed antibody-drug conjugate (trastuzumab emtansine: T-DM1) are used for the treatment of HER2-overexpressing breast cancer. These results suggest that tumors with acquired resistance to trastuzumab and pertuzumab and to T-DM1 are still dependent on oncogenic HER2-HER3 signaling and are vulnerable to HER2 signal inhibition by TAS0728. These results provide a rationale for TAS0728 therapy for breast cancers that are refractory to established anti-HER2 therapies.

Taken together, our results demonstrated that TAS0728 may offer a promising therapeutic option with improved efficacy as compared to current HER2 inhibitors for HER2-activated cancers. Assessment of TAS0728 in ongoing clinical trials is awaited (NCT03410927).

P1/2, N=19, Active, not recruiting, Taiho Oncology, Inc. | Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> Jun 2020