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Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Trial sites expanded: 12 → 18 locations Show 4 more changesShow less
    • Eligibility criteria shortened, about 35 words
    • Secondary endpoints revised (11)
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 4 words
  2. Trial status: Active, Not Recruiting to Recruitingv7 Show 10 more changesShow less
    • Primary completion date: May 14, 2026 to Jun 30, 2028
    • Primary endpoints: 3 to 2
    • Enrollment target: 220 to 181
    • Study sites: 7 to 12
    • Study completion date: Dec 14, 2026 to Sep 30, 2028
    • Secondary endpoints: 15 to 11
    • Study arms: 4 to 3
    • Eligibility criteria shortened, about 2 words
    • Study description shortened, about 1 word
    • Study title expanded, about 1 word
  3. Trial status: Recruiting to Active, Not Recruitingv6 Show 7 more changesShow less
    • Enrollment target: 260 to 220
    • Study sites: 6 to 7
    • Interventions: ART6043 (Drug), Niraparib (Drug), Olaparib (Drug) to ART6043 (Drug), Olaparib (Drug)
    • Secondary endpoints: details revised at 7 of 15 entries
    • Study description shortened, about 10 words
    • Study arms: 5 to 4
    • Eligibility criteria shortened, about 3 words
  4. Primary endpoints: 2 to 3v5 Show 6 more changesShow less
    • Enrollment target: 240 to 260
    • Study sites: 4 to 6
    • Interventions: ART6043 (Drug), Niraparib (Drug), Niraparib (Drug), Olaparib (Drug), Olaparib (Drug) to ART6043 (Drug), Niraparib (Drug), Olaparib (Drug)
    • Secondary endpoints revised (15)
    • Study description shortened, about 46 words
    • Study arms: 4 to 5
  5. Enrollment target: 250 to 240v4 Show 4 more changesShow less
    • Interventions: ART6043 (Drug), Olaparib (Drug), Olaparib (Drug), Talazoparib (Drug), Talazoparib (Drug) to ART6043 (Drug), Niraparib (Drug), Niraparib (Drug), Olaparib (Drug), Olaparib (Drug)
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 7 of 15 entries
    • Study description expanded, about 18 words
Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 2 to 4v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Jun 2, 2023 to Jun 30, 2023
    v2
  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.
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
Trial Details
NCT Number NCT05898399
Lead Sponsor Artios Pharma Ltd
Conditions
(from sponsor)		 Advanced Solid Tumor, Metastatic Solid Tumor
Related terms Neoplasm Metastasis
Enrollment 181 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov