A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental TPX-0131 |
The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131. |
|
More Details
- Status
- Terminated
- Sponsor
- Turning Point Therapeutics, Inc.
Study Contact
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.