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A Clinical Study of KK2260 in Patients With Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Study sites: 13 to 14v6
  2. Study sites: 10 to 13v5
  3. Primary endpoints revised (46)
    • Enrollment target: 169 to 189
    • Study sites: 7 to 10
    v4
  4. Primary completion date: Nov 30, 2028 to Oct 31, 2029v3 Show 7 more changesShow less
    • Primary endpoints revised (46)
    • Enrollment target: 139 to 169
    • Study sites: 2 to 7
    • Study completion date: May 31, 2029 to Apr 30, 2030
    • Start date: Oct 10, 2023 to Nov 1, 2023
    • Eligibility criteria expanded, about 83 words
    • Secondary endpoints revised (10)
  5. Site details revised at 1 of 2 sitesv2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is the first in human study of KK2260. In Part 1a, the maximum tolerated dose (MTD) will be determined while evaluating the safety and tolerability of KK2260 in patients with advanced or metastatic solid tumors (any cancer type). In Part 1b and Part 2, at least two dosing regimens and two dosing regimens by cancer type, respectively, will be selected, and the safety, tolerability, and efficacy of each regimen will be evaluated.
Trial Details
NCT Number NCT06248411
Lead Sponsor Kyowa Kirin Co., Ltd.
Conditions
(from sponsor)		 Advanced or Metastatic Solid Tumors
Enrollment 189 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov