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NCT04849273
A Study of TPX-0131, a Novel Oral ALK Tyrosine Kinase Inhibitor, in Patients With ALK+ Advanced or Metastatic NSCLC
Phase 1 trial testing TPX-0131 in Non Small Cell Lung Cancer in 11 participants. Terminated before completion.
18 April 2023
Quick facts
| Lead sponsor | Turning Point Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 28 July 2021 |
| Primary completion | 18 April 2023 |
| Estimated completion | 18 April 2023 |
| Sites | 15 locations across United States, Australia, South Korea |
Drugs / interventions tested
- TPX-0131 — full drug profile →
Conditions studied
- Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →
- Non-Small Cell Lung Cancer — all drugs for Non-Small Cell Lung Cancer →
- NSCLC — all drugs for NSCLC →
- Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Sponsor
Turning Point Therapeutics, Inc. — full company profile →
Who can join
18 and older, any sex, with Non Small Cell Lung Cancer or Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Third-generation EGFR and ALK inhibitors: mechanisms of resistance and management.
Cooper AJ, Sequist LV, Lin JJ. · · 2022 · cited 382× · PMID 35534623 · DOI 10.1038/s41571-022-00639-9 -
Targeted therapy in advanced non-small cell lung cancer: current advances and future trends.
Majeed U, Manochakian R, Zhao Y, Lou Y. · · 2021 · cited 193× · PMID 34238332 · DOI 10.1186/s13045-021-01121-2 -
ALK-positive lung cancer: a moving target.
Schneider JL, Lin JJ, Shaw AT. · · 2023 · cited 131× · PMID 36797503 · DOI 10.1038/s43018-023-00515-0 -
Oncogenic alterations in advanced NSCLC: a molecular super-highway.
Friedlaender A, Perol M, Banna GL, Parikh K, et al · · 2024 · cited 91× · PMID 38347643 · DOI 10.1186/s40364-024-00566-0 -
TPX-0131, a Potent CNS-penetrant, Next-generation Inhibitor of Wild-type ALK and ALK-resistant Mutations.
Murray BW, Zhai D, Deng W, Zhang X, et al · · 2021 · cited 68× · PMID 34158340 · DOI 10.1158/1535-7163.mct-21-0221 -
Targeted therapy for advanced anaplastic lymphoma kinase (<I>ALK</I>)-rearranged non-small cell lung cancer.
Cameron LB, Hitchen N, Chandran E, Morris T, et al · · 2022 · cited 47× · PMID 34994987 · DOI 10.1002/14651858.cd013453.pub2 -
Targeting ALK Rearrangements in NSCLC: Current State of the Art.
Peng L, Zhu L, Sun Y, Stebbing J, et al · · 2022 · cited 39× · PMID 35463328 · DOI 10.3389/fonc.2022.863461 -
NVL-655 Is a Selective and Brain-Penetrant Inhibitor of Diverse ALK-Mutant Oncoproteins, Including Lorlatinib-Resistant Compound Mutations.
Lin JJ, Horan JC, Tangpeerachaikul A, Swalduz A, et al · · 2024 · cited 38× · PMID 39269178 · DOI 10.1158/2159-8290.cd-24-0231
Verify or expand the search:
- PubMed search for NCT04849273
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07306624 — Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer · Phase 2 · recruiting
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Other Turning Point Therapeutics, Inc. trials
Trials by the same sponsor.
- NCT05828303 — A Phase 1 Study to Evaluate the Potential Drug Interactions Between Repotrectinib and Metformin, Digoxin, and Rosuvastat · Phase 1 · withdrawn
- NCT05828277 — A Phase 1 Study to Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Repotrectinib in Advanced Cancer P · Phase 1 · withdrawn
- NCT05001516 — Study of Turning Point Therapeutics LM-302 in Patients With Advance Solid Tumors · Phase 1 · completed
- NCT05071183 — A Study of Repotrectinib in Combination With Other Anticancer Therapies for the Treatment of Subjects With KRAS-Mutant S · Phase 1, PHASE2 · terminated
- NCT04094610 — A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations · Phase 1, PHASE2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04849273 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Turning Point Therapeutics, Inc.
- Last refreshed: 26 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04849273.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing