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.
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
6
sites
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1500 E Duarte Rd
Duarte, California 91010
Duarte, California 91010
(626) 256-4673
Phone: 626-256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Phone: 516-470-6901
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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114 Rue Edouard Vaillant
Paris, 94800
Paris, 94800
Phone: +33 142 114 385
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