China-based Changzhou Qianhong Bio-pharma Co., Ltd (SHE: 002550) has announced the completion of enrollment and clinical observation in a Phase I clinical study for its Category 1 drug QHRD107, targeting acute myeloid leukemia (AML). Preliminary findings indicate that the QHRD107 capsule is safe for AML patients, with controllable overall risk and established Phase II clinical recommended dose. The drug also demonstrated certain anti – leukemia activity as a monotherapy, suggesting potential benefits for some AML patients.
Phase I Study Design and Results
The multi – center, open, dosage – escalation Phase I study was designed to explore the safety, tolerability, and pharmacokinetics of QHRD107, alongside its preliminary efficacy in AML. During the study, no dose – limiting toxicity events were observed, and the drug’s toxicity profile was consistent with non – clinical study results. No additional safety concerns were identified, and the overall risk remained manageable. Efficacy benefits were observed in some subjects, indicating the drug’s potential therapeutic value.
Future Clinical Development
Based on the Phase I findings, the established clinical recommended dose or a lower dose will be used in subsequent clinical studies to further confirm the safety, tolerability, and efficacy of QHRD107 in AML patients. This marks a significant step forward in the development of QHRD107, positioning it as a potential new treatment option for patients with acute myeloid leukemia.-Fineline Info & Tech
