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A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
SponsorExelixis
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary endpoints revised (9) Enrollment target: 425 to 429 · Interventions: Olaparib (Drug), XL309 (ISM3091) (Drug) to Olaparib (Drug), XL309 (Drug) · Eligibility criteria shortened, about 166 words · 3 morev19 Show 6 more changesShow less
    • Enrollment target: 425 to 429
    • Interventions: Olaparib (Drug), XL309 (ISM3091) (Drug) to Olaparib (Drug), XL309 (Drug)
    • Eligibility criteria shortened, about 166 words
    • Secondary endpoints revised (5)
    • Site details revised at 1 of 16 sites
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  2. Site details revised at 1 of 16 sitesv18
  3. Start date: Aug 17, 2023 to Apr 3, 2024 Primary endpoints: 6 to 9 · Enrollment target: 377 to 425 · Eligibility criteria expanded, about 26 words · 1 morev17 Show 4 more changesShow less
    • Primary endpoints: 6 to 9
    • Enrollment target: 377 to 425
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 13 to 16v16
  5. Study sites: 12 to 13v15
Show 13 earlier versionsHide 13 earlier versions
  1. Study sites: 11 to 12v14
  2. Study sites: 10 to 11v13
  3. Study sites: 9 to 10v12
  4. Study sites: 7 to 9v11
  5. Study sites: 6 to 7v10
  6. Study sites: 5 to 6v9
  7. Study sites: 4 to 5v8
  8. Enrollment target: 66 to 377 Primary completion date: Jul 27, 2024 to Jan 3, 2029 · Primary endpoints: 2 to 6 · Study sites: 2 to 4 · 6 morev7 Show 9 more changesShow less
    • Primary completion date: Jul 27, 2024 to Jan 3, 2029
    • Primary endpoints: 2 to 6
    • Study sites: 2 to 4
    • Completion date: Dec 9, 2025 to Aug 3, 2029
    • Interventions: XL309 (ISM3091) (Drug) to Olaparib (Drug), XL309 (ISM3091) (Drug)
    • Eligibility criteria expanded, about 374 words
    • Secondary endpoints: 15 to 4
    • Study title expanded, about 7 words
    • Study arms: 2 to 4

    See this version in full on ClinicalTrials.gov ↗

  9. Eligibility criteria shortened, about 4 wordsv6 See this version in full on ClinicalTrials.gov ↗
  10. Lead sponsor: InSilico Medicine Hong Kong Limited to Exelixis Interventions: ISM3091 (Drug) to XL309 (ISM3091) (Drug) · Eligibility criteria expanded, about 86 words · Secondary endpoints revised (15) · 2 morev5 Show 5 more changesShow less
    • Interventions: ISM3091 (Drug) to XL309 (ISM3091) (Drug)
    • Eligibility criteria expanded, about 86 words
    • Secondary endpoints revised (15)
    • Study sites revised (2)
    • Study title shortened, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  11. Study sites revised (2)v4 See this version in full on ClinicalTrials.gov ↗
  12. Re-verified, no change to tracked fieldsv3
  13. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Jul 13, 2023 to Aug 17, 2023v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Jul 13, 2023 to Aug 17, 2023
  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.
Exelixis
25 trials monitored
See 2 trials at risk
This is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.
Trial Details
NCT Number NCT05932862
Lead Sponsor Exelixis
Conditions Advanced Solid Tumor
Enrollment 429 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov