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

NCT04849273 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: CA226-1036TPX-0131-01
• Study Type: interventional
• Target: 11
• Locations: 3 countries
• Sites: 15

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).

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Incidence of first cycle dose-limiting toxicities (DLTs) of TPX-0131

  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

  Determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of TPX-0131

  Approximately 24 months

Secondary Outcomes (1)

• Adverse events (AEs)

  Approximately 34 months

Study Arms (1)

TPX-0131

EXPERIMENTAL

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

Drug: TPX-0131

Interventions

TPX-0131 DRUG

Oral TPX-0131 tablets

TPX-0131

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turning Point Therapeutics, Inc.: lead

Study Sites (15)

Local Institution - 2104

Orange, California, 92868, United States

Location

Local Institution - 2105

Aurora, Colorado, 80045, United States

Location

Local Institution - 2106

Boston, Massachusetts, 02114-2696, United States

Location

Local Institution - 2108

Boston, Massachusetts, 02215, United States

Location

Local Institution - 2103

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 2107

Nashville, Tennessee, 37203, United States

Location

Local Institution - 2102

Fairfax, Virginia, 22031-4629, United States

Location

Local Institution - 6102

Blacktown, New South Wales, 2148, Australia

Location

Local Institution - 6103

Heidelberg, Victoria, 3084, Australia

Location

Local Institution - 6104

Melbourne, Victoria, 3000, Australia

Location

Local Institution - 6101

Nedlands, Western Australia, 6009, Australia

Location

Local Institution - 6303

Seoul, Seoul-teukbyeolsi, 05505, South Korea

Location

Local Institution - 6301

Seoul, 03722, South Korea

Location

Local Institution - 6302

Seoul, 06351, South Korea

Location

Local Institution - 6304

Seoul, 110-744, South Korea

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis; Lung Neoplasms

Interventions

TPX-0131

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2021
• First Posted: April 19, 2021
• Study Start: July 28, 2021
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Locations

AU (4); KR (4); US (7)