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

NCT03410927

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.

Related Conditions:
  • Adenocarcinoma of the Gastroesophageal Junction
  • Biliary Tract Neoplasm
  • Breast Carcinoma
  • Colorectal Carcinoma
  • Endometrial Carcinoma
  • Gastric Carcinoma
  • Non-Small Cell Lung Carcinoma
  • Urothelial Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: TO-TAS0728-101
  • SECONDARY ID: 2017-004415-39
  • NCT ID: NCT03410927

Conditions

  • Advanced Solid Tumors
  • HER2 Abnormalities
  • HER3 Abnormalities

Interventions

DrugSynonymsArms
TAS0728TAS0728

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TAS0728ExperimentalGroup 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)
  • TAS0728

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of patients experiencing Dose Limiting Toxicity graded according to CTCAE Version 4.03, observed in the Cycle 1 in order to meet the objective of assessment of the MTD of TAS0728.
Time Frame:21-day cycles
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Maximum Plasma Concentration (Cmax) after administration of TAS0728 (Phase 1)
Time Frame:21 days in Cycle 1
Safety Issue:
Description:
Measure:Area under the plasma drug concentration-time curve (AUC) after administration of TAS0728 (Phase 1)
Time Frame:21 days in Cycle 1
Safety Issue:
Description:
Measure:Disease Control Rate using RECIST 1.1 (phase 1 and 2a)
Time Frame:3 years
Safety Issue:
Description:
Measure:Progression free survival (phase 1 and 2a)
Time Frame:3 years
Safety Issue:
Description:
Measure:Duration of response (phase 1 and 2a)
Time Frame:3 years
Safety Issue:
Description:
Measure:Overall survival (phase 1 and 2a)
Time Frame:3 years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Taiho Oncology, Inc.

Trial Keywords

  • Phase I
  • solid tumors
  • pharmacokinetics
  • pharmacodynamics
  • MTD
  • TAS0728
  • HER2
  • HER3 mutation
  • amplification or overexpression
  • Urothelial cancer with HER2 or HER3 mutation
  • Biliary tract cancer with HER2 or HER3 mutation
  • MBC with HER2 amplification or overexpression or HER3 mutation
  • NSCLC with HER2 or HER3 mutation
  • CRC with HER2 or HER3 mutation
  • amplification

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