Trials / Terminated
TerminatedNCT04849273
A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
A Phase 1/2 Study of TPX-0131, A Novel Oral ALK Tyrosine Kinase Inhibitor in Subjects With ALK+ Advanced or Metastatic NSCLC
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- Turning Point Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
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.
Conditions
- Non Small Cell Lung Cancer
- Non-Small Cell Lung Cancer
- NSCLC
- Advanced Solid Tumor
- Metastatic Solid Tumor
- ALK Gene Mutation
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TPX-0131 | Oral TPX-0131 tablets |
Timeline
- Start date
- 2021-07-28
- Primary completion
- 2023-04-18
- Completion
- 2023-04-18
- First posted
- 2021-04-19
- Last updated
- 2023-05-26
Locations
15 sites across 3 countries: United States, Australia, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04849273. Inclusion in this directory is not an endorsement.