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A Study of BRY812 for Injection Alone in Subjects With Advanced Malignancies

StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Secondary endpoints: details revised at 1 of 6 entriesv3
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Oct 2023 to Oct 10, 2023
    • Site details revised
    • Eligibility criteria expanded, about 1 word
    • Study title shortened, about 2 words
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase I, multicenter, open-label, single-arm and first-in-human clinical study of BRY812 for injection. The study objectives are to evaluate the safety, tolerability, pharmacokinetic profile, anti-tumor activity and immunogenicity of BRY812 for injection in patients with advanced malignancies. Patients will receive treatment every 3 weeks until intolerable toxicity, disease progression, pregnancy, withdrawal of informed consent, death, study discontinuation, or withdrawal from the study.
Trial Details
NCT Number NCT06038058
Lead Sponsor BioRay Pharmaceutical Co., Ltd.
Conditions
(from sponsor)		 Advanced Malignancies
Enrollment 164 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov