A Study of SKB315 in Patients With Advanced Solid Tumors

StatusRecruiting
PhasePhase 1
Started

Record status This record was last updated May 8, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Re-verified, no change to tracked fieldsv6
  2. Primary completion date: Dec 31, 2025 to Jun 30, 2026v5 Show 6 more changesShow less
    • Enrollment target: 206 to 246
    • Study completion date: Feb 28, 2026 to Jun 30, 2028
    • Interventions: SKB315 for injection (Drug) to Drug: Tagitanlimab Drug: Capecitabine (Drug), SKB315 for injection (Drug)
    • Eligibility criteria expanded, about 190 words
    • Study description expanded, about 35 words
    • Study arms: 2 to 3
  3. Lead sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. to Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
    • Primary completion date: May 31, 2024 to Dec 31, 2025
    • Study completion date: May 31, 2024 to Feb 28, 2026
    v4
  4. Re-verified, no change to tracked fieldsv3
  5. Study title shortened, about 3 wordsv2
  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 a multicenter, open-label, multiple-dose dose finding and expansion study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and anti-tumor efficacy of SKB315 for injection in patients with advanced solid tumors.
Trial Details
NCT Number NCT05367635
Lead Sponsor Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Advanced Solid Tumors
Enrollment 246 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov