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

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ClinicalTrials.gov Identifier: NCT03410927
Recruitment Status : Recruiting
First Posted : January 25, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors HER2 Abnormalities HER3 Abnormalities Drug: TAS0728 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 204 participants
Intervention Model: Sequential Assignment
Intervention Model Description: In Phase 1, TAS0728 will be evaluated for safety and tolerability, and in phase 2a will be evaluated preliminary efficacy.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 6, 2018
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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)
Drug: 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.




Primary Outcome Measures :
  1. 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 ]
  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (Phase 1 and 2a) [ Time Frame: Safety monitoring will begin at the informed consent obtained and continue up to 30 days after the last dose of TAS0728 or until new antitumor therapy, whichever is earlier. ]
  3. Objective Response Rate using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST) (Phase2a) [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) after administration of TAS0728 (Phase 1) [ Time Frame: 21 days in Cycle 1 ]
  2. Area under the plasma drug concentration-time curve (AUC) after administration of TAS0728 (Phase 1) [ Time Frame: 21 days in Cycle 1 ]
  3. Disease Control Rate using RECIST 1.1 (phase 1 and 2a) [ Time Frame: 3 years ]
  4. Progression free survival (phase 1 and 2a) [ Time Frame: 3 years ]
  5. Duration of response (phase 1 and 2a) [ Time Frame: 3 years ]
  6. Overall survival (phase 1 and 2a) [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03410927


Contacts
Contact: Mark Kirshbaum, MD 609-750-5300 MKirschbaum@taihooncology.com

Locations
United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
Contact: Sumanta Pal    626-256-4673    SPal@coh.org   
United States, Georgia
Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Suresh S. Ramalingam    404-778-5378    ellie.butler@emory.edu   
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029-6504
Contact: Matthew Galsky    516-470-6901    matthew.galsky@mssm.edu   
United States, Tennessee
Sarah Cannon Recruiting
Nashville, Tennessee, United States, 37203
Contact: Johanna Bendell    615-524-4461    jbendell@tnonc.com   
United States, Texas
University of Texas - MD Anderson Recruiting
Houston, Texas, United States, 77030
Contact: Sarina Piha-Paul    713-563-1055    spihapau@mdanderson.org   
France
Institut de Cancerologie Gustavo Roussy Not yet recruiting
Paris, France, 94800
Contact: Antoine Hollebecque, MD    +33 142 114 385    Antoine.hollebecque@gustaveroussy.fr   
Spain
Hospital Vall D'hebron Recruiting
Barcelona, Spain, 8035
Contact: Josep Tabernero, MD    +34 93 274 6085    itabernero@vhio.net   
United Kingdom
Sarah Cannon Research Institute - UK Recruiting
London, United Kingdom, W1G 6AD
Contact: Hendrick-Tobias Arkenau, MD    +02 03 219 5200    Tobias.Arkenau@HCAHealthcare.co.uk   
Sponsors and Collaborators
Taiho Oncology, Inc.

Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT03410927     History of Changes
Other Study ID Numbers: TO-TAS0728-101
2017-004415-39 ( EudraCT Number )
First Posted: January 25, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taiho Oncology, Inc.:
TAS0728
Phase I
solid tumors
pharmacokinetics
pharmacodynamics
MTD
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

Additional relevant MeSH terms:
Congenital Abnormalities