A Phase I Study to Evaluate the Safety, Tolerability, and PK of HLX43 in Advanced/Metastatic Solid Tumors

StatusEnrolling by Invitation
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 6 months later Jun 30, 2026 → Dec 30, 2026
See other at-risk trials from Shanghai Henlius Biotech

Record History

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  1. Primary completion pushed from Jun 30, 2026 to Dec 30, 2026
    • Trial sites expanded: 10 → 14 locations
    • Eligibility criteria expanded, about 27 words
    • Secondary endpoints: details revised at 2 of 9 entries
  2. Trial status changed: Recruiting → Enrolling by Invitation
    • Site details revised at 10 of 10 sites
    v8
  3. Enrollment target: 340 to 367
    • Study sites: 2 to 10
    v7
  4. Enrollment target: 174 to 340v6 Show 7 more changesShow less
    • Primary endpoints: 2 to 4
    • Interventions: HLX43 (Drug) to HLX10 (Drug), HLX43 (Drug)
    • Eligibility criteria expanded, about 494 words
    • Secondary endpoints: 10 to 9
    • Study description expanded, about 81 words
    • Site details revised at 1 of 2 sites
    • Study arms: 1 to 5
  5. Enrollment target: 36 to 174
    • Study description expanded, about 33 words
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Primary completion date: Jun 30, 2025 to Jun 30, 2026
    • Study completion date: Nov 30, 2025 to Nov 30, 2027
    • Start date: Nov 28, 2023 to Nov 24, 2023
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Nov 15, 2023 to Nov 28, 2023
    • Secondary endpoints expanded, about 29 words
    v3
  3. Re-verified, no change to tracked fieldsv2
  1. 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 study is an open-label first-in-human phase I clinical study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HLX43 in patients with advanced/metastatic solid tumors.
Trial Details
NCT Number NCT06115642
Lead Sponsor Shanghai Henlius Biotech
Conditions
(from sponsor)		 Advanced/Metastatic Malignant Solid Tumors
Enrollment 367 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov