NCT03786926

Trial to Evaluate the Safety and Pharmacokinetics of HMPL-689 in Patients With Lymphomas

A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-689 in Patients With Relapsed or Refractory Lymphoma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Hutchmed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability and PK of HMPL-689 in patients with relapsed or refractory lymphomas

Detailed description

This is a Phase 1, open-label, multicenter study of HMPL-689 administered orally to patients with relapsed or refractory lymphoma. HMPL-689 is a selective and potent small molecule inhibitor targeting the isoform phosphoinositide 3'-kinase delta (PI3Kδ), a key component in the B-cell receptor signaling pathway This study will consist of a dose escalation stage (Stage 1) and a dose expansion stage (Stage 2). Dose Escalation Stage (Stage 1): This stage will end when any of the following criteria is met: * The dose level 1 demonstrates an excessive toxicity, ie, 3 dose limiting toxicities (DLTs) are observed out of the first 3 patients at dose level 1. * The maximum sample size is reached. * The MTD and/or RP2D is confirmed. Dose Expansion Stage (Stage 2): To further characterize the safety and explore the preliminary anti-tumor activity of HMPL-689 at RP2D, patients with B cell lymphoma will be enrolled in the dose expansion stage.

Conditions

• Lymphoma

Interventions

Type	Name	Description
DRUG	HMPL-689	HMPL-689 is a PI3Kδ inhibitor

Timeline

• Start date: 2019-08-26
• Primary completion: 2024-06-26
• Completion: 2024-06-26
• First posted: 2018-12-26
• Last updated: 2025-06-26
• Results posted: 2025-06-26

Locations

27 sites across 6 countries: United States, Finland, France, Italy, Poland, Spain

Regulatory

• FDA-regulated drug study