HMPL-306

P3, N=316, Not yet recruiting, Hutchmed

P1, N=75, Recruiting, Hutchmed | Trial completion date: Sep 2023 --> Jun 2025 | Trial primary completion date: Sep 2023 --> Sep 2024

P1, N=90, Active, not recruiting, Hutchmed | Recruiting --> Active, not recruiting

Combing with safety, tolerability, PK/PD and preliminary efficacy, the RP2D was set as 250 mg QD at Cycle 1, and then with 150 mg QD from Cycle 2. Dose expansion is ongoing. Clinical trialinformation: NCT04272957.

P1, N=90, Recruiting, Hutchmed | Trial completion date: Jan 2023 --> Sep 2023 | Trial primary completion date: Jan 2023 --> Sep 2023

P1, N=75, Recruiting, Hutchmed | Trial completion date: Jan 2023 --> Sep 2023 | Trial primary completion date: Jan 2023 --> Sep 2023

Oral administration of HMPL-306 remarkably decreased 2-HG level in plasma and tumor tissues in xenograft models carrying mIDH1 or mIDH2 and the inhibition is more potent and durable than either ivosidenib or enasidenib at the same dose...Combination treatment of HMPL-306 and azacitidine synergized in releasing the differentiation block in mIDH AML cells. HMPL-306 is a potent, dual inhibitor of IDH1/2 mutation. The strong activity and favorable PK profiles support further clinical evaluation.

Safety endpoints will include dose limiting toxicities, treatment emergent adverse event and serious adverse events. Efficacy endpoints will include objective response rate, time to response, and duration of response.

P1, N=75, Recruiting, Hutchison Medipharma Limited | Not yet recruiting --> Recruiting

P1, N=75, Not yet recruiting, Hutchison Medipharma Limited