ranosidenib (HMPL-306)

P1, N=42, Terminated, Hutchmed | N=90 --> 42 | Trial completion date: Sep 2025 --> Feb 2025 | Active, not recruiting --> Terminated; The study was terminated based on strategic evaluation of the clinical development of HMPL-306 with no safety concerns

P3, N=316, Recruiting, Hutchmed | Trial completion date: Jun 2028 --> Sep 2029 | Trial primary completion date: Jun 2027 --> Dec 2028

P1, N=52, Recruiting, Hutchmed | Not yet recruiting --> Recruiting

P1, N=6, Completed, Hutchmed | Active, not recruiting --> Completed

P1, N=52, Not yet recruiting, Hutchmed

Hu et al. report the results of a phase 1 study of the dual IDH1/2 inhibitor HMPL-306 in relapsed/refractory IDH-mutant AML.1 The study highlights its manageable safety profile and robust preliminary efficacy, suggesting that it may be a valuable AML therapy.

P3, N=790, Recruiting, Peking University People's Hospital; Peking University People's Hospital

P1, N=46, Terminated, Hutchmed | N=75 --> 46 | Trial completion date: Jun 2025 --> Jan 2025 | Recruiting --> Terminated | Trial primary completion date: Sep 2024 --> Jan 2025; The study was terminated based on strategic evaluation of the clinical development of HMPL-306 with no safety concerns

It demonstrated favorable preclinical pharmacokinetics and safety profiles, reduced 2-HG in vivo robustly and sustainably in the mutant IDH1 and 2 tumor xenograft models, and displayed high brain penetration in mice. In the clinical studies, the drug showed good safety and encouraging efficacy in patients with relapsed/refractory myeloid malignancies carrying IDH1 and/or IDH2 mutations.

P1, N=6, Active, not recruiting, Hutchmed | Recruiting --> Active, not recruiting

HMPL-306 showed an acceptable safety profile and promising preliminary efficacy. A phase 3, randomized study of HMPL-306 in R/R AML (this study was registered at ClinicalTrials.gov: NCT06387069) has been initiated.

P1, N=8, Recruiting, Hutchmed | Not yet recruiting --> Recruiting