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Closed (no longer recruiting)Last updated: 5 February 2024

TPX-0131-01: This Phase I/II trial is trying to understand how safe and effective a targeted therapy (TPX-0131) is in people with ALK+ advanced or metastatic Non-Small Cell Lung CancerA Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC

Clinical summary

Summary

This trial has two experimental phases. Phase 1 is assessing the safety, tolerability, PK, MTD, and RP2D of TPX-0131. Phase 2 will determine the safety, tolerability, PK and preliminary efficacy of TPX-0131 in specific cohorts. Participants will receive TPX-0131 via oral tablets.

Conditions

This trial is treating patients with Non-Small Cell Lung Cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

I/II

Trial Acronym

TPX-0131-01

More information

Trial Identifiers

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Trial sponsor

Turning Point Therapeutics, Inc.

Scientific Title

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

Eligibility

Inclusion

  • 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

  • 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.

Inclusion

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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