Trial | NCT05304377  Report issue

Title

A Phase 1a/1b Study of ELVN-001 for the Treatment Chronic Myeloid Leukemia
A Phase 1a/1b Study of ELVN-001 for the Treatment of Chronic Myeloid Leukemia

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Recruiting

  • Study Participants

    120
The purpose of this study is to evaluate the safety, tolerability and determine the recommended dose for further clinical evaluation of ELVN-001 in patients with chronic myeloid leukemia with and without T315I mutations in patients who are relapsed, refractory or intolerant to TKIs.
This first-in-human trial with ELVN-001 is a dose escalation study whose primary purpose is to identify the recommended dose for expansion RDE of single agent ELVN-001 in chronic phase or accelerated phase CML with and without T315I mutations. The safety tolerability and pharmacokinetic profile of ELVN-001 will be assessed together with an evaluation of changes in BCR-ABL1 transcript. An understanding of the RDE safety profile, PK and preliminary evidence of anti-CML activity will be used to inform future development in adults with CML. By virtue of its predicted pharmacological profile ELVN-001 has the potential to be tolerable and achieve a deep molecular response in patients with CML with or without T315I mutations who do not tolerable or benefit from available TKIs.
Study Started
May 22
2022
Primary Completion
Dec 31
2026
Anticipated
Study Completion
Dec 31
2026
Anticipated
Last Update
Apr 24
2023

Drug ELVN-001

orally once daily

phase 1b expansion arm at recommended dose level 1 Experimental

ELVN-001 administered orally once daily at RDE-1 in CML without T315I mutations

Phase 1b expansion arm at recommended dose level 2 Experimental

ELVN-001 administered orally once daily at RDE-2 in CML without T315I mutations

Phase 1b expansion arm in T315I mutated CML Experimental

ELVN-001 administered orally once daily at RDE-3

Phase 1a dose escalation in CML Experimental

ELVN-001 administered orally once daily in 3+3 dose escalation

Criteria 

Inclusion Criteria:

CML that has failed or the patient is intolerant to available therapies known to be active for treatment of their CML.
ECOG performance status of 0 to 2.
Adequate hematologic, hepatic and renal function.

Exclusion Criteria:

Treatment with anti-cancer or anti-CML therapy within 7 days or 5 half-lives, whichever is longer.
QTc >470 ms.
No Results Posted