Purpose

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.

Conditions

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/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
TPX-0131
The Phase 1 part of the study will determine the safety, tolerability, PK, MTD, and RP2D of TPX-0131. The Phase 2 part of the study will determine the safety, tolerability, PK and preliminary efficacy of TPX-0131 in specific cohorts.
  • Drug: TPX-0131
    Oral TPX-0131 tablets

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114

More Details

Status
Recruiting
Sponsor
Turning Point Therapeutics, Inc.

Study Contact

Eric Park, M.D
(858) 276-0005
clinical@tptherapeutics.com

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. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.