A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
NCT04849273 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2023-05-26
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 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
Interventions
- DRUG
-
TPX-0131
Oral TPX-0131 tablets
Sponsors & Collaborators
-
Turning Point Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-07-28
- Primary Completion
- 2023-04-18
- Completion
- 2023-04-18
- FDA Drug
- Yes
Countries
- United States
- Australia
- South Korea
Study Locations
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