for people ages 18 years and up (full criteria)
at Orange, California and other locations
study started
estimated completion



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.

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


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.


Non Small Cell Lung Cancer, Non-Small Cell Lung Cancer, NSCLC, Advanced Solid Tumor, Metastatic Solid Tumor, ALK Gene Mutation, Advanced Non-Small Cell Lung Cancer, Advanced/metastatic disease, Lung cancer, ALK gene fusion, ALK inhibitor, TPX-0131, ALK TKI, ALK Tyrosine Kinase Inhibitor, Neoplasms, Lung Neoplasms, Non-Small-Cell Lung Carcinoma


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.


  • UC Irvine Health - Chao Family Comprehensive Cancer Center
    Orange California 92868 United States
  • University of Colorado, Anschutz Medical Campus
    Aurora Colorado 80045 United States


in progress, not accepting new patients
Start Date
Completion Date
Turning Point Therapeutics, Inc.
Phase 1/2 research study
Study Type
About 11 people participating
Last Updated