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

May 24, 2023 updated by: Turning Point Therapeutics, Inc.

A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC

A phase 1, 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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Local Institution - 6102
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 6103
      • Melbourne, Victoria, Australia, 3000
        • Local Institution - 6104
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution - 6101
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Local Institution - 6301
      • Seoul, Korea, Republic of, 06351
        • Local Institution - 6302
      • Seoul, Korea, Republic of, 110-744
        • Local Institution - 6304
    • Seoul-teukbyeolsi
      • Seoul, Seoul-teukbyeolsi, Korea, Republic of, 05505
        • Local Institution - 6303
  • United States
    • California
      • Orange, California, United States, 92868
        • Local Institution - 2104
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Local Institution - 2105
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2696
        • Local Institution - 2106
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 2108
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Local Institution - 2103
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Local Institution - 2107
    • Virginia
      • Fairfax, Virginia, United States, 22031-4629
        • Local Institution - 2102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Drug: TPX-0131
Oral TPX-0131 tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 28 days of the first TPX-0131 dose for each patient
Define the Recommended Phase 2 Dose
Time Frame: Approximately 24 months
Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131
Approximately 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs)
Time Frame: Approximately 34 months
Evaluate the overall safety profile of TPX-0131
Approximately 34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turning Point Therapeutics, Inc.

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2021

Primary Completion (Actual)

April 18, 2023

Study Completion (Actual)

April 18, 2023

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 26, 2023

Last Update Submitted That Met QC Criteria

May 24, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA226-1036 (Other Identifier: BMS Protocol ID)
  • TPX-0131-01 (Other Identifier: Turning Point Therapeutics Protocol ID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-Small Cell Lung Cancer

Clinical Trials on TPX-0131

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe