NCT03410927

A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities

Terminated Phase 1 Last updated 5 September 2024

What this trial tests

Phase 1 trial testing TAS0728 in Advanced Solid Tumors With HER2 Abnormalities in 19 participants. Terminated before completion.

Timeline

6 April 2018

Primary endpoint
9 June 2022

9 June 2022

Quick facts

Lead sponsor	Taiho Oncology, Inc.
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	6 April 2018
Primary completion	9 June 2022
Estimated completion	9 June 2022
Sites	8 locations across France, United Kingdom, United States, Spain

Drugs / interventions tested

• TAS0728 — full drug profile →

Conditions studied

• Advanced Solid Tumors With HER2 Abnormalities — all drugs for Advanced Solid Tumors With HER2 Abnormalities →
• Advanced Solid Tumors With HER3 Abnormalities — all drugs for Advanced Solid Tumors With HER3 Abnormalities →

Sponsor

Taiho Oncology, Inc. — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors With HER2 Abnormalities or Advanced Solid Tumors With HER3 Abnormalities. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a First-in-Human (FIH), 2-part, Phase 1/2, open-label, multicenter study design to evaluate the safety, tolerability, PK, pharmacodynamics, PGx, and efficacy of TAS0728. This study consists of Phase 1 and Phase 2 components in subjects with advanced solid tumors with HER2 or HER3 overexpression, amplification, or mutation who have progressed despite standard therapy or for which no standard therapy exists, particularly urothelial cancer, biliary tract cancer, metastatic breast cancer, non-small cell lung cancer and colorectal cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prevalence and role of HER2 mutations in cancer.
   Cocco E, Lopez S, Santin AD, Scaltriti M. · · 2019 · cited 73× · PMID 30951733 · DOI 10.1016/j.pharmthera.2019.03.010
2. Evolution of the Targeted Therapy Landscape for Cholangiocarcinoma: Is Cholangiocarcinoma the 'NSCLC' of GI Oncology?
   Gupta A, Kurzrock R, Adashek JJ. · · 2023 · cited 19× · PMID 36900367 · DOI 10.3390/cancers15051578
3. Evaluation of the Clinical Utility of Genomic Profiling to Inform Selection of Clinical Trial Therapy in Salivary Gland Cancer.
   Rack S, Feeney L, Hapuarachi B, Adderley H, et al · · 2022 · cited 10× · PMID 35267442 · DOI 10.3390/cancers14051133
4. Advances in HER2-Targeted Treatment for Advanced/Metastatic Urothelial Carcinoma.
   Qu M, Zhou L, Yan X, Li S, et al · · 2023 · cited 9× · PMID 38155921 · DOI 10.14440/bladder.2023.871
5. TAS0728, A Covalent-binding, HER2-selective Kinase Inhibitor Shows Potent Antitumor Activity in Preclinical Models.
   Irie H, Ito K, Fujioka Y, Oguchi K, et al · · 2019 · cited 8× · PMID 30787176 · DOI 10.1158/1535-7163.mct-18-1085
6. A first-in-human phase I study of TAS0728, an oral covalent binding inhibitor of HER2, in patients with advanced solid tumors with HER2 or HER3 aberrations.
   Piha-Paul SA, Azaro A, Arkenau HT, Oh DY, et al · · 2021 · cited 4× · PMID 33774767 · DOI 10.1007/s10637-021-01104-7
7. 4-Aminopyrazolopyrimidine scaffold and its deformation in the design of tyrosine and serine/threonine kinase inhibitors in medicinal chemistry.
   Chen X, Huang Y, Xu W, Cai Y, et al · · 2022 · cited 1× · PMID 36324498 · DOI 10.1039/d2md00139j
8. A First-in-human Phase I Study of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in Patients With Advanced Solid Tumors With HER2 or HER3 Aberrations.
   Piha-Paul SA, Azaro A, Arkenau HT, Oh D, et al · · 2021 · DOI 10.21203/rs.3.rs-297672/v1