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Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 22 → 27 locations Eligibility criteria expanded, about 11 words · Secondary endpoints: details revised at 3 of 6 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: details revised at 3 of 6 entries
  2. Trial sites expanded: 18 → 22 locations Eligibility criteria expanded, about 7 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 16 to 18 Eligibility criteria expanded, about 2 wordsv10 Show 1 more changeShow less
    • Eligibility criteria expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  4. Enrollment target: 212 to 282 Study sites: 9 to 16 · Eligibility criteria shortened, about 92 words · Secondary endpoints: details revised at 1 of 6 entriesv9 Show 3 more changesShow less
    • Study sites: 9 to 16
    • Eligibility criteria shortened, about 92 words
    • Secondary endpoints: details revised at 1 of 6 entries

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: 60 to 212 Primary completion date: May 20, 2025 to Dec 2027 · Trial status: Completed to Recruiting · Completion date: May 20, 2025 to Dec 2028 · 1 morev8 Show 4 more changesShow less
    • Primary completion date: May 20, 2025 to Dec 2027
    • Trial status: Completed to Recruiting
    • Completion date: May 20, 2025 to Dec 2028
    • Site details revised at 9 of 9 sites
Show 6 earlier versionsHide 6 earlier versions
  1. Trial status: Recruiting to Completed Enrollment target: estimated 212 to confirmed 60 · Primary completion date changed from estimate of Dec 2027 to May 20, 2025 · Study completion date changed from estimate of Dec 2028 to May 20, 2025 · 1 morev7 Show 4 more changesShow less
    • Enrollment target: estimated 212 to confirmed 60
    • Primary completion date changed from estimate of Dec 2027 to May 20, 2025
    • Study completion date changed from estimate of Dec 2028 to May 20, 2025
    • Site details revised at 9 of 9 sites
  2. Study sites: 7 to 9 Eligibility criteria revisedv6 Show 1 more changeShow less
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 6 to 7 Eligibility criteria revised · Study title revisedv5 Show 2 more changesShow less
    • Eligibility criteria revised
    • Study title revised

    See this version in full on ClinicalTrials.gov ↗

  4. Study sites: 4 to 6 Eligibility criteria shortened, about 7 words · Primary endpoints revised (3)v4 Show 2 more changesShow less
    • Eligibility criteria shortened, about 7 words
    • Primary endpoints revised (3)

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 1 to 4v3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of May 2024 to Apr 4, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2024 to Apr 4, 2024
  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.
Xencor
10 trials monitored
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Ovarian Cancer
1,245 trials monitored
See 80 trials at risk
Endometrial Cancer
633 trials monitored
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The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.
Trial Details
NCT Number NCT06276491
Lead Sponsor Xencor, Inc.
Conditions Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor, Testicular Germ Cell Tumor, Ovarian Germ Cell Tumor
Enrollment 282 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov