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A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC

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ClinicalTrials.gov Identifier: NCT04849273
Recruitment Status : Recruiting
First Posted : April 19, 2021
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Turning Point Therapeutics, Inc.

Brief Summary:
A phase 1/2, first-in-human, open-label study to evaluate the safety, tolerability, PK, and efficacy of the novel ALK inhibitor TPX-0131 in pretreated subjects with ALK+ advanced or metastatic non-small cell lung cancer (NSCLC). The study consists of two portions: 1) Phase 1 dose escalation, and 2) Phase 2 efficacy evaluation.

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Non-Small Cell Lung Cancer NSCLC Advanced Solid Tumor Metastatic Solid Tumor ALK Gene Mutation Drug: TPX-0131 Phase 1 Phase 2

Detailed Description:

Phase 1 Dose Escalation: To evaluate the overall safety profile, efficacy of TPX-0131 in pretreated subjects with ALK+ advanced or metastatic NSCLC.

Phase 2 Efficacy Evaluation: To determine the safety and anti-tumor efficacy of TPX-0131 in defined cohorts of subjects with advanced or metastatic ALK+ NSCLC.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC
Actual Study Start Date : March 29, 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TPX-0131

The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131.

The Phase 2 part of the study will determine the safety, tolerability, PK and preliminary efficacy of TPX-0131 in specific cohorts.

Drug: TPX-0131
Oral TPX-0131 tablets




Primary Outcome Measures :
  1. Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131 [ Time Frame: Within 28 days of the first TPX-0131 dose for each patient ]
    Evaluate the safety and tolerability of TPX-0131

  2. Define the Recommended Phase 2 Dose [ Time Frame: Approximately 22 months ]
    Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131

  3. Define the objective response rate (ORR) [ Time Frame: Approximately 44 months ]
    Determine the preliminary efficacy by the ORR in defined cohorts with ALK+ advanced or metastatic NSCLC


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Approximately 44 months ]
    Determine the DOR of TPX-0131

  2. Time to response (TTR) [ Time Frame: Approximately 44 months ]
    Determine the TTR of TPX-0131

  3. Clinical benefit rate (CBR) [ Time Frame: Approximately 44 months ]
    Determine the CBR of TPX-0131

  4. Intracranial tumor response [ Time Frame: Approximately 44 months ]
    Determine the intracranial tumor response in subjects with measurable brain metastases, as determined by BICR.

  5. Progression free survival (PFS) [ Time Frame: Approximately 44 months ]
    Determine the PFS of TPX-0131

  6. Overall survival (OS) [ Time Frame: Approximately 44 months ]
    Determine the efficacy and safety of TPX-0131

  7. Adverse events (AEs) [ Time Frame: Approximately 44 months ]
    Evaluate the overall safety profile of TPX-0131

  8. CNS Progression-Free Survival (CNS-PFS) [ Time Frame: Approximately 44 months ]
    Determine the CNS-PFS in patients with measurable brain metastases using Modified RECIST v1.1

  9. Cmax (maximum plasma concentration) of TPX-0131 [ Time Frame: Up to 120 hours post-dose ]
    Evaluate the maximum plasma concentration of TPX-0131

  10. AUC (area under plasma concentration time curve) of TPX-0131 [ Time Frame: Up to 120 hours post-dose ]
    Determine the AUC of TPX-0131

  11. Patient-reported quality of life - Core Quality of Life Questionnaire [ Time Frame: Approximately 44 months ]
    Estimate the effect of TPX-0131 on patient-reported outcomes using the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire to assess subject's ability to complete 30 daily activities. The scale, from 1 to 4 (1 = not difficult to 4 = very difficult), indicates the level of difficulty to complete a task.

  12. Patient-reported quality of life - Lung Cancer Quality of Life Questionnaire [ Time Frame: Approximately 44 months ]

    Estimate the effect of TPX-0131 on patient-reported outcomes, using the Lung Cancer Quality of Life Questionnaire asks questions related to 13 specific lung cancer symptoms. The scale, from 1 to 4

    (1 = not often to 4 = very often), indicates the frequency of symptoms experienced in a given week.




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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:

  • Age ≥ 18 (or as required by local regulation).
  • Histological or cytological confirmation of advanced/metastatic ALK+ NSCLC.
  • Pretreated with up to three prior lines of an ALK TKI treatment, including at least one prior line of a second or third-generation ALK TKI (alectinib, brigatinib, ensartinib, or lorlatinib) in Phase 1.
  • ECOG performance status ≤ 1.
  • Existence of measurable or evaluable disease (according to Response evaluation criteria in solid tumors [RECIST v1.1] criteria).
  • Subjects with asymptomatic CNS metastases and/or asymptomatic leptomeningeal carcinomatosis are eligible.
  • Adequate organ function.

Exclusion Criteria:

  • Major surgery within four weeks of the start of TPX-0131 treatment.
  • Clinically significant cardiovascular disease
  • Any of the following cardiac criteria:

    • Mean resting corrected QT interval (QTc) > 470 msec obtained from three ECGs and any factors that increase the risk of QTc prolongation or arrhythmic events
    • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
  • Known clinically significant active infections not controlled with systemic treatment (bacterial, fungal, viral including HIV positivity).
  • Gastrointestinal disease or other malabsorption syndromes that would impact drug absorption.
  • Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
  • Subjects with current or anticipated need for drugs that are sensitive CYP2C9 substrates with narrow therapeutic indices.

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): NCT04849273


Contacts
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Contact: Eric Park, M.D (858) 276-0005 clinical@tptherapeutics.com

Locations
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United States, California
UC Irvine Health - Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Principal Investigator: Fa-Chyi Lee, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Jessica Jiyeong Lin, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Principal Investigator: Mark Awad, MD, PhD         
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Principal Investigator: Martin E. Gutierrez, MD         
United States, Tennessee
Sarah Cannon Research Institute at Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Principal Investigator: Melissa Johnson, MD         
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Principal Investigator: Alexander I. Spira, MD         
Australia, New South Wales
Blacktown Cancer and Hematology Centre Recruiting
Blacktown, New South Wales, Australia, 2148
Principal Investigator: Adnan Nagrial, MD         
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Principal Investigator: Prof. Benjamin Solomon         
Australia, Western Australia
Linear Clinical Research Recruiting
Nedlands, Western Australia, Australia, 6009
Principal Investigator: Dr. Michael Millward         
Sponsors and Collaborators
Turning Point Therapeutics, Inc.
Investigators
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Study Director: Eric Park, M.D. Turning Point Therapeutics
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Responsible Party: Turning Point Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04849273    
Other Study ID Numbers: TPX-0131-01
First Posted: April 19, 2021    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Turning Point Therapeutics, Inc.:
TPX-0131
Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer
NSCLC
Advanced Non-Small Cell Lung Cancer
Advanced/metastatic disease
Lung cancer
Metastatic solid tumor
Advanced solid tumor
ALK gene fusion
ALK inhibitor
ALK TKI
ALK Tyrosine Kinase Inhibitor
Additional relevant MeSH terms:
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Neoplasms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms