Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
estimated completion
Principal Investigator
by Misako Nagasaka, MD (uci)

Description

Summary

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

Details

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.

Keywords

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 Carcinoma, Non-Small-Cell Lung

Eligibility

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.

Locations

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

Lead Scientist at University of California Health

  • Misako Nagasaka, MD (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 100 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Turning Point Therapeutics, Inc.
ID
NCT04849273
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 210 study participants
Last Updated