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A Study of TRK-950 in Patients With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Dec 2027 → Mar 31, 2028
See other at-risk trials from Toray Industries, Inc

Record History

  1. Primary and study completion pushed from Dec 2027 to Mar 31, 2028 Eligibility criteria expanded, about 13 words · Secondary endpoints: details revised at 1 of 13 entries · Publications: details revised at 2 of 2 entries Show 3 more changesShow less
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 13 entries
    • Publications: details revised at 2 of 2 entries
  2. Study sites: 9 to 10v19
  3. Study sites: 6 to 9v18
  4. Study sites: 3 to 6v17
  5. Trial status: Active, Not Recruiting to Recruiting Study sites: 2 to 3v16 Show 1 more changeShow less
    • Study sites: 2 to 3
Show 14 earlier versionsHide 14 earlier versions
  1. Study sites: 1 to 2v15
  2. Phase: Phase 1 to Phase 1/2 Enrollment target: 13 to 49 · Primary endpoints: 4 to 5 · Interventions: Nivolumab (Drug), TRK-950 (Biological), TRK-950 (Biological), TRK-950 (Biological) to Nivolumab (Drug), TRK-950 (Biological), TRK-950 (Biological), TRK-950 (Biological), TRK-950 (Biological) · 4 morev14 Show 7 more changesShow less
    • Enrollment target: 13 to 49
    • Primary endpoints: 4 to 5
    • Interventions: Nivolumab (Drug), TRK-950 (Biological), TRK-950 (Biological), TRK-950 (Biological) to Nivolumab (Drug), TRK-950 (Biological), TRK-950 (Biological), TRK-950 (Biological), TRK-950 (Biological)
    • Eligibility criteria expanded, about 28 words
    • Secondary endpoints: 7 to 13
    • Study description expanded, about 34 words
    • Study arms: 3 to 4

    See this version in full on ClinicalTrials.gov ↗

  3. Primary and study completion dates: Jun 2025 to Dec 2027v13
  4. Primary and study completion dates: Feb 2025 to Jun 2025v12
  5. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 19 to confirmed 13 · Site details revisedv11 Show 2 more changesShow less
    • Enrollment target: estimated 19 to confirmed 13
    • Site details revised
  6. Trial status: Active, Not Recruiting to Recruiting Enrollment target: 7 to 19 · Primary and study completion dates: Dec 2023 to Feb 2025 · Interventions: TRK-950 (Biological) to Nivolumab (Drug), TRK-950 (Biological), TRK-950 (Biological), TRK-950 (Biological) · 5 morev10 Show 8 more changesShow less
    • Enrollment target: 7 to 19
    • Primary and study completion dates: Dec 2023 to Feb 2025
    • Interventions: TRK-950 (Biological) to Nivolumab (Drug), TRK-950 (Biological), TRK-950 (Biological), TRK-950 (Biological)
    • Eligibility criteria expanded, about 31 words
    • Secondary endpoints: 6 to 7
    • Study description expanded, about 57 words
    • Site details revised
    • Study arms: 1 to 3

    See this version in full on ClinicalTrials.gov ↗

  7. Re-verified, no change to tracked fieldsv9
  8. Primary and study completion dates: Jul 2023 to Dec 2023v8
  9. Re-verified, no change to tracked fieldsv7
  10. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 12 to confirmed 7 · Site details revisedv6 Show 2 more changesShow less
    • Enrollment target: estimated 12 to confirmed 7
    • Site details revised
  11. Primary endpoints: 3 to 4v5 See this version in full on ClinicalTrials.gov ↗
  12. Start date changed from estimate of Jul 4, 2022 to Jul 6, 2022v4
  13. Trial status: Not Yet Recruiting to Recruiting Site details revisedv3 Show 1 more changeShow less
    • Site details revised
  14. Re-verified, no change to tracked fieldsv2
  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.
Toray Industries, Inc
4 trials monitored
See 2 trials at risk
Melanoma
1,026 trials monitored
See 48 trials at risk
Part 1 • To determine the safety and tolerability of TRK-950 in patients with advanced solid tumors Part 2 • To determine the safety and tolerability of TRK-950 in combination with nivolumab(NIVO) in patients with advanced solid tumors eligible for NIVO therapy Part 3 • To determine the efficacy of TRK-950 in patients with advanced/recurrent unresectable melanoma, who received prior chemotherapy with dacarbazine(DTIC) and for whom no standard therapy exists
Trial Details
NCT Number NCT05423262
Lead Sponsor Toray Industries, Inc
Conditions Solid Tumor, Melanoma
Enrollment 49 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov