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Phase I Study of FXS0683 in the Treatment of Blood Tumors

Study acronym: FXS0683-001
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Notable Recruitment opened Show 5 more changesShow less
    • Primary endpoints: details revised at 1 of 2 entries
    • Interventions modified
    • Start date changed from estimate of Jun 1, 2026 to Jun 2, 2026
    • Eligibility criteria expanded, about 31 words
    • Site details revised
  2. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, multicenter, open-label, single-arm Phase I study of FXS0683 in participants with relapsed or refractory hematologic malignancies to evaluate safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity, and to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).
Trial Details
NCT Number NCT07616089
Lead Sponsor Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Conditions
(from sponsor)
B-Cell Lymphoma, Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia
Related terms Leukemia, Myeloid, Acute, Lymphoma, B-Cell, Myelodysplastic Syndromes, Precursor Cell Lymphoblastic Leukemia-Lymphoma
Enrollment 228 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov