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Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint added 4 → 5 primary endpoints
See other at-risk trials from Qilu Pharmaceutical Co., Ltd.

Record History

  1. Primary endpoint(s) modified Recruitment opened · Start date changed from estimate of Jun 5, 2026 to Jun 9, 2026 · Interventions: Darolutamide (Drug), Itraconazole (Drug), QLC5508 (Investigational Product / Formulation T) (Drug), QLC5508 (Reference Product /… to Darolutamide (Drug), Itraconazole (Drug), QLC5508 (Investigational Product / Formulation T) (Drug), QLC5508 (Reference Product /… · 3 more Show 6 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Jun 5, 2026 to Jun 9, 2026
    • Interventions: Darolutamide (Drug), Itraconazole (Drug), QLC5508 (Investigational Product / Formulation T) (Drug), QLC5508 (Reference Product /… to Darolutamide (Drug), Itraconazole (Drug), QLC5508 (Investigational Product / Formulation T) (Drug), QLC5508 (Reference Product /…
    • Eligibility criteria expanded, about 29 words
    • Site details revised
    • Study title expanded, about 4 words
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
A clinical trial of QLC5508 for advanced solid tumors The goal of this clinical trial is to learn if QLC5508 can be given safely to adults with advanced solid tumors. It will also learn how two different formulations of QLC5508 compare in the body, and whether other drugs affect QLC5508. The main questions it aims to answer are: Does a single injection of QLC5508 change the heart's electrical activity (QTc interval)? How do the test formulation and the reference formulation of QLC5508 compare in the body (pharmacokinetics)? Do other drugs (itraconazole, darolutamide, or rifampicin) change how the body processes QLC5508? Investigators will compare the test formulation to the reference formulation, and will also give QLC5508 together with itraconazole, darolutamide, or rifampicin to look for drug-drug interactions. Participants will: Receive QLC5508 by injection into a vein; Join one of three groups: two groups will receive both formulations of QLC5508 at different times (crossover) and also take rifampicin or itraconazole; the third group will take darolutamide with QLC5508; Have heart monitoring (Holter) during the first dose; Undergo regular blood tests, safety checks, and immunogenicity testing (to see if the body develops antibodies against QLC5508).
Trial Details
NCT Number NCT07620041
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Refractory or Relapsed Solid Tumors
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov