A Study of ME-401 in Subjects With CLL/SLL, FL, and B-cell Non Hodgkin's Lymphoma

Phase 1 Terminated 97 enrolled MEI Pharma, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

A Three-Arm Study of ME-401 in Subjects with Relapsed/Refractory CLL/SLL or FL, of ME-401 in Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL, and of ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL

Timeline

Start: 2016-10
Primary completion: 2023-03-29
Completion: 2023-03-29

Outcome

Outcome not reported

Stopped: “discontinuation of zandelisib program”

Publications

Pagel JM, Soumerai JD, Reddy N, Jagadeesh D, Stathis A, Asch A, Salman H, Kenkre VP, Iasonos A, Llorin-Sangalang J, Li J, Zelenetz AD. Zandelisib with continuous or intermittent dosing as monotherapy or in combination with rituximab in patients with relapsed or refractory B-cell malignancy: a multicentre, first-in-patient, dose-escalation and dose-expansion, phase 1b trial. Lancet Oncol. 2022 Aug;23(8):1021-1030. doi: 10.1016/S1470-2045(22)00333-3. Epub 2022 Jul 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zandelisib	Small molecule	60 mg	Oral
Subject	Zandelisib	Small molecule	120 mg	Oral
Subject	Zandelisib	Small molecule	180 mg	Oral
Background	Rituximab	Monoclonal antibody	375 mg/m2	Intravenous
Background	Zanubrutinib	Small molecule	80 mg	—
Background	Zanubrutinib	Small molecule	160 mg	—