Status:
TERMINATED
A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
Lead Sponsor:
Turning Point Therapeutics, Inc.
Conditions:
Non Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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.
Eligibility Criteria
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.
Key Trial Info
Start Date :
July 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT04849273
Start Date
July 28 2021
End Date
April 18 2023
Last Update
May 26 2023
Active Locations (15)
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1
Local Institution - 2104
Orange, California, United States, 92868
2
Local Institution - 2105
Aurora, Colorado, United States, 80045
3
Local Institution - 2106
Boston, Massachusetts, United States, 02114-2696
4
Local Institution - 2108
Boston, Massachusetts, United States, 02215