OncoMatch/Clinical Trials/NCT07470762
Study of Safety and Efficacy of HS-10542 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Is NCT07470762 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including HS-10542 and HS-10542 for paroxysmal nocturnal hemoglobinuria.
Treatment: HS-10542 · HS-10542 · HS-10542 — This was a phase 1b/2,open label, multi-center study to assess efficacy and safety of HS-10542 in adulte patients with paroxysmal nocturnal hemoglobinuria (PNH) with signs of active hemolysis.
Check if I qualifyExtracted eligibility criteria
Prior therapy
Must have received: C5 complement inhibitor (ikuzumab, covalimab) — stable use for first 6 months of random treatment
Stable use of C5 complement inhibitor ikuzumab/covalimab for the first 6 months of random treatment
Must have received: blood transfusion — at least one within last 4 months
Have at least one blood transfusion record within the last 4 months
Cannot have received: B-factor inhibitor
Exception: treatment duration of no more than one week and stopped for more than five half-lives before screening
Participants who have previously received B-factor inhibitor treatment, with a treatment duration of no more than one week and having stopped taking the drug for more than five half-lives before screening, may not be excluded
Lab requirements
Blood counts
reticulocytes <100x10^9/L; platelets <30x10^9/L; neutrophils <0.5x10^9/L
Kidney function
severe kidney disease (eGFR<30 mL/min/1.73 m2, dialysis)
Liver function
ALT/ALP >3×ULN
Cardiac function
advanced heart disease (such as NYHA level IV); abnormal ECG: QTcF >450 msec for males and >470 msec for females; or other clinically significant abnormalities
Patients with laboratory evidence of bone marrow failure (reticulocytes <100x10^9/L; platelets <30x10^9/L; neutrophils <0.5x10^9/L); advanced heart disease (such as NYHA level IV); abnormal ECG: The absolute value of QTcF (QT interval corrected by Fridericia 's formula > 450 msec for males and > 470 msec for females; or other clinically significant abnormalities as judged by the investigator. severe kidney disease (such as eGFR<30 mL/min/1.73 m2, dialysis), ALT/ALP>3×ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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