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

Active:	No
Cancer Type:	Leukemia Lymphoma Non-Hodgkin Lymphoma	NCT ID:	NCT03786926
Trial Phases:	Phase I	Protocol IDs:	2018-689-US001 (primary) NCI-2019-01158 2018-689-00US1
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Hutchmed
NCI Full Details:	http://clinicaltrials.gov/show/NCT03786926

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

Objectives

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 (PI3Kd), 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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