Receive our newsletter – data, insights and analysis delivered to you
  1. News
September 4, 2019updated 23 Dec 2019 9:33am

Chi-Med starts new trial of HMPL-689 in lymphoma patients

Hutchison China MediTech (Chi-Med) has started a Phase I/Ib clinical trial to investigate its small molecule, HMPL-689, for treating patients with advanced relapsed or refractory lymphoma.

Hutchison China MediTech (Chi-Med) has started a Phase I/Ib clinical trial to investigate its small molecule, HMPL-689, for treating patients with advanced relapsed or refractory lymphoma.

HMPL-689 is a selective inhibitor of the isoform phosphoinositide-3 kinase delta (PI3Kδ).

The open-label, two-stage, international Phase I/Ib study will evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of oral HMPL-689.

The trial, which includes dose-escalation and expansion stages, will enrol around 85 patients at sites in the US and Europe. The first participant was dosed last month in the US.

The dose-escalation part will be concluded when the first three patients dosed at level one will experience three dose-limiting toxicities (DLTs), when the maximum sample size is achieved, or when maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) is confirmed.

In the dose-expansion stage, patients with B cell lymphoma will be enrolled to further characterise the safety and analyse the preliminary anti-tumour activity of HMPL-689 at RP2D.

Content from our partners
The importance of reference products in biosimilar trials, and how to source them
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success

The primary outcome measures of the study are safety and tolerability. The trial will also monitor pharmacokinetic measurements and preliminary efficacy, including objective response rate, as secondary outcomes.

Chi-Med expects to complete the Phase I/Ib trial by April 2023. The company noted that the new study supports a Phase I/Ib dose-escalation and expansion trial of HMPL-689 being conducted in China.

Around 83 lymphoma patients who did not experience an adequate response to standard care or do not have standard of care will be enrolled in the country.

The primary outcome of the trial is the incidence of dose limited toxicities and related HMPL-689 dose, while secondary outcomes are maximum plasma concentration and time to reach maximum concentration.

The study is expected to be completed in 2021.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU