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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-06

Study Completion Date

2022-06-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Solid Tumors With HER2 Abnormalities Advanced Solid Tumors With HER3 Abnormalities

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

In Phase 1, TAS0728 will be evaluated for safety and tolerability, and in phase 2 will be evaluated preliminary efficacy.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAS0728

Group 1: Urothelial cancer with HER2 or HER3 mutation Group 2: Biliary tract cancer with HER2 or HER3 mutation Group 3: Breast cancer with HER2 or HER3 mutation Group 4: Breast cancer with HER2 amplification or overexpression as per American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) 2013 guidelines Group 5: Non-small cell lung cancer (NSCLC) with HER2 or HER3 mutation Group 6: Colorectal cancer (CRC) with HER2 mutation or amplification Group 7: Other tumors with HER2 or HER3 mutation, amplification, or overexpression (eg, gastric or gastroesophageal junction (GEJ), endometrial)

Group Type EXPERIMENTAL

TAS0728

Intervention Type DRUG

TAS0728 is an oral HER2 covalent inhibitor investigated in patients with advanced solid tumor harboring HER2 or HER3 abnormalities. It will be administered orally at a starting dose of 50 mg BID each morning and evening and escalated to the DLT. The MTD will be used for the phase 2 arms of the study.

Interventions

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TAS0728

TAS0728 is an oral HER2 covalent inhibitor investigated in patients with advanced solid tumor harboring HER2 or HER3 abnormalities. It will be administered orally at a starting dose of 50 mg BID each morning and evening and escalated to the DLT. The MTD will be used for the phase 2 arms of the study.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No