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Study of TPX-0022 in Patients With Advanced NSCLC, Gastric Cancer or Solid Tumors Harboring Genetic Alterations in MET

Study acronym: SHIELD-1
StatusActive, Not Recruiting
PhasePhase 1
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv22
  2. Study completion date: Mar 31, 2026 to Mar 3, 2027v21
  3. Phase: Phase 1/2 to Phase 1v20 Show 5 more changesShow less
    • Enrollment target: estimated 180 to confirmed 95
    • Primary completion date changed from estimate of Mar 2, 2025 to Jan 8, 2024
    • Study completion date: Mar 2, 2025 to Mar 31, 2026
    • Start date: Sep 21, 2019 to Sep 5, 2019
    • Site details revised at 2 of 24 sites
  4. Primary and study completion dates: Nov 30, 2023 to Mar 2, 2025v19
  5. Trial status: Recruiting to Active, Not Recruiting
    • Study sites revised (24)
    v18
Show 16 earlier versionsHide 16 earlier versions
  1. Study sites revised (24)v17
  2. Primary and study completion dates: Nov 2023 to Nov 30, 2023
    • Study sites revised (24)
    v16
  3. Re-verified, no change to tracked fieldsv15
  4. Primary endpoints revised (2)
    • Interventions: TPX-0022 (Drug) to elzovantinib (TPX-0022) (Drug)
    • Secondary endpoints revised (12)
    • Eligibility criteria expanded, about 3 words
    v14
  5. Enrollment target: 330 to 180v13 Show 4 more changesShow less
    • Primary completion date: Nov 2022 to Nov 2023
    • Start date: Aug 20, 2019 to Sep 21, 2019
    • Eligibility criteria expanded, about 20 words
    • Site contacts updated at 6 of 24 sites
  6. Study title shortened, about 5 wordsv12
  7. Phase: Phase 1 to Phase 1/2v11 Show 5 more changesShow less
    • Enrollment target: 120 to 330
    • Study sites: 22 to 24
    • Eligibility criteria shortened, about 39 words
    • Study description shortened, about 20 words
    • Study title expanded, about 4 words
  8. Study sites: 18 to 22v10
  9. Study sites: 13 to 18v9
  10. Study sites: 10 to 13v8
  11. Site details revised at 1 of 10 sitesv7
  12. Study sites: 8 to 10v6
  13. Study sites: 7 to 8
    • Start date changed from estimate of Dec 2019 to Aug 20, 2019
    v5
  14. Site details revised at 1 of 7 sitesv4
  15. Site details revised at 2 of 7 sitesv3
  16. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 3 to 7
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
A phase 1/2, first-in-human, open-label study of the safety, tolerability, PK, and efficacy of the novel MET/CSF1R/SRC inhibitor TPX-0022 in adult subjects with advanced or metastatic NSCLC, Gastric Cancer, or solid tumors harboring genetic alterations in MET. (SHIELD-I)
Trial Details
NCT Number NCT03993873
Lead Sponsor Turning Point Therapeutics, Inc.
Conditions
(from sponsor)		 Advanced Solid Tumor, Metastatic Solid Tumors, MET Gene Alterations
Related terms Adenocarcinoma of Lung, Carcinoma, Non-Small-Cell Lung, Liver Neoplasms, Lung Neoplasms, Neoplasm Metastasis, Neoplasms, Stomach Neoplasms
Enrollment 95 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov