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A Study of TRK-950 in Combinations With Anti-Cancer Treatment Regimens in Patients With Advanced Solid Tumors

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary and study completion dates changed from estimate of Jun 2026 to Jul 16, 2026 · Eligibility criteria expanded, about 41 words · Publications: details revised at 1 of 1 entry Show 3 more changesShow less
    • Primary and study completion dates changed from estimate of Jun 2026 to Jul 16, 2026
    • Eligibility criteria expanded, about 41 words
    • Publications: details revised at 1 of 1 entry
  2. 2 versions Re-verified since Jul 30, 2025, no change to tracked fieldsv26-v27
  3. Enrollment target: estimated 187 to confirmed 138v25
  4. Primary and study completion dates: Mar 2025 to Jun 2026 Trial status: Recruiting to Active, Not Recruiting · Site details revised at 14 of 14 sitesv24 Show 2 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 14 of 14 sites
  5. Re-verified, no change to tracked fieldsv23
Show 21 earlier versionsHide 21 earlier versions
  1. Eligibility criteria expanded, about 47 words Site details revised at 4 of 14 sitesv22 Show 1 more changeShow less
    • Site details revised at 4 of 14 sites

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion dates: Aug 2024 to Mar 2025 Enrollment target: 169 to 187 · Interventions: 5-FU (Drug), Bevacizumab (Biological), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Irinotecan (Drug)… to 5-FU (Drug), Bevacizumab (Drug), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Irinotecan (Drug)… · Eligibility criteria expanded, about 208 words · 4 morev21 Show 7 more changesShow less
    • Enrollment target: 169 to 187
    • Interventions: 5-FU (Drug), Bevacizumab (Biological), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Irinotecan (Drug)… to 5-FU (Drug), Bevacizumab (Drug), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Irinotecan (Drug)…
    • Eligibility criteria expanded, about 208 words
    • Secondary endpoints: 11 to 10
    • Site details revised at 1 of 14 sites
    • Study arms: 14 to 15
    • Study description expanded, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv20
  4. Primary endpoints: 11 to 12 Enrollment target: 181 to 169 · Study sites: 13 to 14 · Eligibility criteria shortened, about 47 words · 2 morev19 Show 5 more changesShow less
    • Enrollment target: 181 to 169
    • Study sites: 13 to 14
    • Eligibility criteria shortened, about 47 words
    • Secondary endpoints: details revised at 1 of 11 entries
    • Study arms: 15 to 14

    See this version in full on ClinicalTrials.gov ↗

  5. Eligibility criteria expanded, about 72 wordsv18 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 12 to 13v17
  7. Study sites: 7 to 12v16
  8. Primary and study completion dates: Dec 2023 to Aug 2024 Enrollment target: 155 to 181 · Eligibility criteria expanded, about 30 words · Secondary endpoints: 10 to 11 · 1 morev15 Show 4 more changesShow less
    • Enrollment target: 155 to 181
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints: 10 to 11
    • Study arms: 14 to 15

    See this version in full on ClinicalTrials.gov ↗

  9. Enrollment target: 75 to 155 Primary and study completion dates: Apr 2021 to Dec 2023 · Interventions: 5-FU (Drug), Bevacizumab (Biological), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Ipilimumab… to 5-FU (Drug), Bevacizumab (Biological), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Irinotecan (Drug)… · Eligibility criteria expanded, about 234 words · 3 morev14 Show 6 more changesShow less
    • Primary and study completion dates: Apr 2021 to Dec 2023
    • Interventions: 5-FU (Drug), Bevacizumab (Biological), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Ipilimumab… to 5-FU (Drug), Bevacizumab (Biological), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Irinotecan (Drug)…
    • Eligibility criteria expanded, about 234 words
    • Secondary endpoints: 3 to 10
    • Study description expanded, about 6 words
    • Study arms: 10 to 14

    See this version in full on ClinicalTrials.gov ↗

  10. Enrollment target: 36 to 75 Primary and study completion dates: Feb 2021 to Apr 2021 · Interventions: 5-FU (Drug), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Irinotecan (Drug), Leucovorin (Drug)… to 5-FU (Drug), Bevacizumab (Biological), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Ipilimumab… · Eligibility criteria expanded, about 146 words · 2 morev13 Show 5 more changesShow less
    • Primary and study completion dates: Feb 2021 to Apr 2021
    • Interventions: 5-FU (Drug), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Irinotecan (Drug), Leucovorin (Drug)… to 5-FU (Drug), Bevacizumab (Biological), Carboplatin (Drug), Cisplatin (Drug), Gemcitabine (Drug), Imiquimod Cream (Drug), Ipilimumab…
    • Eligibility criteria expanded, about 146 words
    • Study description expanded, about 7 words
    • Study arms: 6 to 10

    See this version in full on ClinicalTrials.gov ↗

  11. Re-verified, no change to tracked fieldsv12
  12. Study sites: 5 to 7v11
  13. Study sites: 4 to 5v10
  14. Study sites: 3 to 4v9
  15. Study sites: 2 to 3v8
  16. Study sites: 1 to 2v7
  17. Start date changed from estimate of Apr 2019 to Apr 26, 2019v6
  18. Start date: Mar 2019 to Apr 2019v5
  19. Trial status: Not Yet Recruiting to Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  20. Re-verified, no change to tracked fieldsv3
  21. Primary endpoints: 10 to 11v2 See this version in full on ClinicalTrials.gov ↗
  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
Colorectal Cancer
2,920 trials monitored
See 132 trials at risk
Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
Gastric Cancer
1,201 trials monitored
See 59 trials at risk
and 4 more diseases
The main purpose of this study is to establish the safety and the recommended dose of TRK-950 in combination with FOLFIRI, Gemcitabine / Cisplatin, Gemcitabine / Carboplatin, Ramucirumab / Paclitaxel, PD1 inhibitors (Nivolumab or Pembrolizumab), and Imiquimod Cream, Bevacizumab, Gemcitabine / Carboplatin / Bevacizumab, Pegylated liposomal doxorubicin (PLD), Carboplatin / PLD / Bevacizumab and Paclitaxel for selected advanced solid tumors.
Trial Details
NCT Number NCT03872947
Lead Sponsor Toray Industries, Inc
Conditions Solid Tumor, Colorectal Cancer, Cholangiocarcinoma, Bladder Cancer, Ovarian Cancer, Gastric Cancer, Palpable Subcutaneous Malignant Lesions, Renal Cell Carcinoma +4 more
Enrollment 138 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov