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

Primary Purpose

Non Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TPX-0131
Sponsored by
Turning Point Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring 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, TPX-0131, ALK TKI, ALK Tyrosine Kinase Inhibitor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Local Institution - 2104
  • Local Institution - 2105
  • Local Institution - 2106
  • Local Institution - 2108
  • Local Institution - 2103
  • Local Institution - 2107
  • Local Institution - 2102
  • Local Institution - 6102
  • Local Institution - 6103
  • Local Institution - 6104
  • Local Institution - 6101
  • Local Institution - 6303
  • Local Institution - 6301
  • Local Institution - 6302
  • Local Institution - 6304

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TPX-0131

Arm Description

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

Outcomes

Primary Outcome Measures

Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131
Evaluate the safety and tolerability of TPX-0131
Define the Recommended Phase 2 Dose
Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131

Secondary Outcome Measures

Adverse events (AEs)
Evaluate the overall safety profile of TPX-0131

Full Information

First Posted
April 12, 2021
Last Updated
May 24, 2023
Sponsor
Turning Point Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04849273
Brief Title
A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Adverse change in the risk/benefit.
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
April 18, 2023 (Actual)
Study Completion Date
April 18, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turning Point Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Advanced Solid Tumor, Metastatic Solid Tumor, ALK Gene Mutation
Keywords
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, TPX-0131, ALK TKI, ALK Tyrosine Kinase Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TPX-0131
Arm Type
Experimental
Arm Description
The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131.
Intervention Type
Drug
Intervention Name(s)
TPX-0131
Intervention Description
Oral TPX-0131 tablets
Primary Outcome Measure Information:
Title
Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131
Description
Evaluate the safety and tolerability of TPX-0131
Time Frame
Within 28 days of the first TPX-0131 dose for each patient
Title
Define the Recommended Phase 2 Dose
Description
Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131
Time Frame
Approximately 24 months
Secondary Outcome Measure Information:
Title
Adverse events (AEs)
Description
Evaluate the overall safety profile of TPX-0131
Time Frame
Approximately 34 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution - 2104
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Local Institution - 2105
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 2106
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114-2696
Country
United States
Facility Name
Local Institution - 2108
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 2103
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Local Institution - 2107
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Local Institution - 2102
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031-4629
Country
United States
Facility Name
Local Institution - 6102
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Local Institution - 6103
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Local Institution - 6104
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Facility Name
Local Institution - 6101
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution - 6303
City
Seoul
State/Province
Seoul-teukbyeolsi
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution - 6301
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Local Institution - 6302
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Local Institution - 6304
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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