Hutchison China MediTech (Chi-Med) has begun a Phase I clinical trial of its therapeutic candidate HMPL-689 to treat patients with non-Hodgkin lymphoma in China.
HMPL-689 is a selective and potent small molecule inhibitor being developed to target the phosphoinositide-3 kinase delta isoform (PI3Kδ) component of B-cell receptor (BCR) signalling pathway.
The multi-centre, open-label, two-part Phase I trial is designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of HMPL-689 as a monotherapy in around 83 relapsed and / or refractory non-Hodgkin lymphoma patients for whom standard care failed or is not available.
While the initial dose escalation part will determine the maximum tolerated dose (MTD) or the recommended Phase II dose (RP2D) as the primary objective, the dose expansion part will investigate the safety, tolerability and preliminary efficacy of HMPL-689 in multiple sub-types of patients.
The trial’s primary outcome measure is incidence of dose limited toxicities, while the secondary outcome measures include maximum plasma concentration and time to reach maximum concentration.
It is expected that the final data for the primary outcome measure will be available in July 2019 and the trial will be completed in January 2020.
In preclinical pharmacokinetic studies, HMPL-689 is reported to have demonstrated good oral absorption, moderate tissue distribution and low clearance.
The firm also carried out another Phase I trial in healthy adult participants in Australia last year to evaluate the pharmacokinetic and safety profile of single oral doses of the investigational agent.
According to the results from this dose escalation trial, HMPL-689 showed linear properties and a favourable safety profile.