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A Study of TAK-188 in Adults With Advanced or Spreading Solid Tumors

StatusRecruiting
PhasePhase 1/2
SponsorTakeda
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 3 of 8 changed
See other at-risk trials from Takeda

Record History

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  1. Primary endpoint(s) modified Show 4 more changesShow less
    • Enrollment increased: 223 → 273 participants
    • Trial arms changed: 6 → 5
    • Eligibility criteria expanded, about 179 words
    • Secondary endpoints: 25 to 18
  2. Eligibility criteria expanded, about 92 words
    • Secondary endpoints: details revised at 16 of 25 entries
    • Site contacts updated at 1 of 15 sites
  3. Site details revised at 1 of 15 sitesv14
  4. Site details revised at 2 of 15 sitesv13
  5. Site contacts updated at 1 of 15 sitesv12
Show 10 earlier versionsHide 10 earlier versions
  1. Site details revised at 1 of 15 sitesv11
  2. Site details revised at 1 of 15 sitesv10
  3. Study sites revised (15)v9
  4. Site details revised at 1 of 15 sitesv8
  5. Site details revised at 1 of 15 sitesv7
  6. Site details revised at 2 of 15 sitesv6
  7. Site details revised at 3 of 15 sitesv5
  8. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 18, 2025 to Nov 19, 2025
    • Site details revised at 15 of 15 sites
    v4
  9. Re-verified, no change to tracked fieldsv3
  10. Study Status, Referencesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Takeda
222 trials monitored
See 14 trials at risk
TAK-188 is a new medicine that targets a protein called CCR8, which is found on the surface of certain cells (Tregs) inside tumors. These cells can weaken the body's ability to fight cancer. TAK-188 may help to remove these Tregs. Removing these Tregs may allow more cancer-fighting cells (CD8+ T cells) to attack the tumor and potentially stop tumors from growing. In this study, researchers want to learn if TAK-188 can help the body's immune system better fight cancer in adults with advanced cancers which have not gotten better with regular treatments. The main aims of this study are to check if TAK-188 is safe in adults with advanced or spreading (metastatic) solid tumors, if participants tolerate the treatment with TAK-188 and to learn if TAK-188 works well in adults with certain advanced cancers after their previous treatments didn't work. Participants may receive TAK-188 for up to 1 year. Their health will be monitored after the treatment has ended for up to another year.
Trial Details
NCT Number NCT07205718
Lead Sponsor Takeda
Conditions
(from sponsor)		 Advanced or Metastatic Solid Tumors
Enrollment 273 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov