A Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of MK-6204 (SKB535) for Injection in Participants With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Enrollment increased: 90 → 142 participants
    • Trial sites expanded: 7 → 10 locations
    • Eligibility criteria expanded, about 3 words
  2. Re-verified, no change to tracked fieldsv5
  3. Eligibility criteria shortened, about 8 words
    • Site contacts updated at 1 of 7 sites
    v4
  4. Site contacts updated at 1 of 7 sitesv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 2024 to Dec 12, 2024
    • Site details revised at 7 of 7 sites
    v2
  6. Study First Submitted
  • 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 an open-label, nonrandomized, multicenter, Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of MK-6204 as monotherapy in participants with advanced solid tumors.
Trial Details
NCT Number NCT06726369
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Advanced Solid Tumors
Enrollment 142 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov