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

Status:	Recruiting
Conditions:	Cancer, Women's Studies
Therapuetic Areas:	Oncology, Reproductive
Healthy:	No
Age Range:	18 - Any
Updated:	8/16/2018
Start Date:	April 6, 2018
End Date:	September 2021
Contact:	Mark Kirshbaum, MD
Email:	MKirschbaum@taihooncology.com
Phone:	609-750-5300

A Phase 1/2, Open Label, Multicenter Study to Investigate the Safety, Pharmacokinetics, and Efficacy of TAS0728, an Oral Covalent Binding Inhibitor of HER2, in Subjects With Advanced Solid Tumors With HER2 or HER3 Abnormalities

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 2a 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.

Inclusion Criteria:

1. Male or females with an age ≥ 18 years.

2. Subjects with histological- or cytological-confirmed, advanced cancer, who have
progressed on (or not been able to tolerate) standard therapy or for whom no standard
anticancer therapy exists

1. For Phase 1, only subjects HER2 or HER3 molecular/genetic alterations will be
enrolled.

2. For Phase 2a, subjects with one of the following tumor types will be enrolled:

i. Urothelial cancer with HER2 or HER3 mutation ii. Biliary tract cancer with HER2 or
HER3 mutation iii. Breast cancer with HER2 or HER3 mutation iv. Breast cancer with
HER2 amplification or overexpression v. NSCLC with HER2 or HER3 mutation vi. CRC with
HER2 mutation or amplification vii. Other tumors with HER2
mutation/amplification/overexpression or HER3 mutation (gastric/GEJ, endometrial).

3. At least 1 measurable lesion for solid tumor

4. Is able to take medications orally (e.g., no feeding tube).

5. Able to agree to and sign informed consent and to comply with the protocol

6. Has adequate organ function

Exclusion Criteria:

1. Has a serious illness or medical condition(s)

2. Has received treatment with any proscribed treatments within specified time frames
prior to study drug administration

3. Impaired cardiac function or clinically significant cardiac disease

We found this trial at

sites

University of Texas - MD Anderson

Houston, Texas 77030

Phone: 713-563-1055

from

Houston, TX