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SW-682 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 3 of 5 entries
  2. Minor 2 versions Re-verified since Aug 7, 2026, no change to tracked fieldsv22-v23
  3. Minor Site details revised at 8 of 8 sitesv21
  4. Notable Primary completion moved earlier from Jan 2030 to Jan 18, 2027
    • Study completion moved earlier from Jun 2030 to Jan 18, 2027
    • Start date: Jul 30, 2024 to Jul 31, 2024
    • Study sites revised (8)
    v20
  5. Notable Sponsor changed: SpringWorks Therapeutics, Inc. to SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germanyv19
Show 17 earlier versionsHide 17 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv18
  2. Minor Study sites: 9 to 8v17
  3. Minor Re-verified, no change to tracked fieldsv16
  4. Minor Study sites: 8 to 9v15
  5. Minor Study sites revised (8)v14
  6. Minor Site details revised at 1 of 8 sitesv13
  7. Minor Study sites: 9 to 8v12
  8. Minor Study sites revised (9)v11
  9. Minor Study sites revised (9)v10
  10. Minor Site details revised at 1 of 9 sitesv9
  11. Minor Start date changed from estimate of Jul 2024 to Jul 30, 2024
    • Study sites revised (9)
    v8
  12. Minor Study sites: 8 to 9v7
  13. Notable Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 8 of 8 sites
    v6
  14. Minor Study sites revised (8)v5
  15. Minor Study sites: 9 to 8v4
  16. Minor Study sites: 0 to 9v3
  17. Minor Re-verified, no change to tracked fieldsv2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a first-in-human (FIH), Phase 1a/1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult participants with metastatic or unresectable advanced solid tumors with or without Hippo pathway alterations that are refractory to, or have progressed, during or after appropriate prior systemic anticancer therapy, including chemotherapy, immunotherapy, radiation therapy or targeted therapy, or for which no treatment is available, or prior standard of care (SOC) therapy was not tolerated and for which there is no further SOC treatment available. The study includes a Part 1 (Phase 1a) dose escalation phase and a Part 2 (Phase 1b) dose expansion to optimize the dose to be used for further development. All participants will self-administer SW-682 by mouth in 28-day cycles.
Trial Details
NCT Number NCT06251310
Lead Sponsor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
Conditions
(from sponsor)
Advanced Solid Tumor, Mesothelioma, Malignant
Related terms Mesothelioma, Malignant
Enrollment 186 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov