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Dose Escalation and Expansion Study of BH3120 Alone or With Pembrolizuamb in Advanced or Metastatic Solid Tumors

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 12% 245 → 216 participants
See other at-risk trials from Hanmi Pharmaceutical Company Limited

Record History

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  1. Enrollment reduced: 245 → 216 participants Show 4 more changesShow less
    • Eligibility criteria expanded, about 24 words
    • Secondary endpoints revised (13)
    • Site details revised at 1 of 10 sites
    • Collaborators: details revised at 1 of 1 entry
  2. Re-verified, no change to tracked fieldsv5
  3. Study sites: 8 to 10v4
  4. Enrollment target: 191 to 245v3 Show 8 more changesShow less
    • Study sites: 9 to 8
    • Primary completion date: Feb 2027 to Aug 2027
    • Study completion date: Jul 2027 to Jan 2028
    • Interventions: BH3120 (Drug) to BH3120 (Drug), pembrolizumab (Drug)
    • Study arms: 1 to 2
    • Eligibility criteria expanded, about 3 words
    • Collaborators expanded, about 5 words
    • Study title expanded, about 4 words
  5. Site details revised at 5 of 9 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of BH3120, as a single agent and in combination with pembrolizumab, to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation part is planned to establish the MTD or RD for Dose-Expansion part, while Dose-Expansion part is designed to assess potential efficacy of BH3120, as a single agent and in combination with pembrolizumab, when administered at the RD to subjects in indication-specific expansion cohorts.
Trial Details
NCT Number NCT06234397
Lead Sponsor Hanmi Pharmaceutical Company Limited
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Advanced or Metastatic Solid Tumors
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov