An Open-label, Phase IIa Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 (a LOXL2 Inhibitor) in Participants With Myelofibrosis (MF)

Galecto Biotech AB11 sites in 4 countries21 target enrollmentJune 9, 2021

ConditionsMyelofibrosis

InterventionsGB2064

DrugsGB2064

Overview

Phase: Phase 2
Intervention: GB2064
Conditions: Myelofibrosis
Sponsor: Galecto Biotech AB
Enrollment: 21
Locations: 11
Primary Endpoint: Safety and tolerability of GB2064: AE
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is an open label, phase IIa trial in subjects with Myelofibrosis

Detailed Description

This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GB2064 a LOXL-2 inhibitor over 9 months. Subjects will receive doses of GB2064, given twice per day to participants with primary or secondary Myelofibrosis

Registry

clinicaltrials.gov

Start Date

June 9, 2021

End Date

June 30, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Galecto Biotech AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Participants must satisfy all of the following criteria at the Screening visit:
•Adult male or female participants ≥ 18 years of age at enrolment:
•Female participants may be of non-childbearing potential defined as permanently sterile or postmenopausal, or female participants considered to be of childbearing potential who agree to use highly effective birth control methods until 90 days after the follow-up visit. Female participants should refrain from ova donation from the date of Enrolment (Day -1) until 90 days after the follow-up visit.
•Male participants will agree to use contraception throughout the study and until 90-days after the Follow-up visit. Male participants must agree to refrain from sperm donation from the date of Enrolment (Day -1) until 90 days after the follow-up visit.
•Diagnosis of PMF or SMF with intermediate -2 or high-risk disease according to the Dynamic International Prognostic Scoring System (DIPSS)-plus or if with low risk disease then with symptomatic splenomegaly as defined by sonographic assessment as spleen length of \>12 cm or by physical examination as ≥ 5 cm below left costal margin.
•Participants who are not currently taking a Janus kinase (JAK) inhibitor (e.g. ruxolitinib or fedratinib) and are therefore refractory, intolerant or ineligible for a JAK inhibitor according to appropriate guidelines (including local guidelines).
•Eastern Cooperative Oncology Group (ECOG) performance status 0-
•Required baseline laboratory status:
•Absolute platelet count (APC) ≥ 50 x 109/L
•Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1500/mm3)

Exclusion Criteria

•Current treatment with a JAK inhibitor (e.g. ruxolitinib or fedratinib) or a history of treatment with a JAK inhibitor within two weeks of enrolment.
•Positive hepatitis panel and/or positive HIV test.
•Any concurrent severe and/or uncontrolled medical conditions that could increase the participant's risk for toxicity while in the study or that could confound discrimination between disease- and study treatment-related toxicities. Any planned major surgery during the study period
•Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
•History or presence of ventricular tachyarrhythmia.
•Presence of unstable atrial fibrillation (ventricular response \> 100 bpm); Participants with stable atrial fibrillation are eligible, provided they do not meet any of the other cardiac exclusion criteria.
•Clinically significant resting bradycardia (\< 50 bpm) and use of a cardiac pacemaker or implantable cardioverter defibrillator.
•Angina pectoris or acute myocardial infarction ≤ 90 days prior to starting study drug.
•Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen).
•Participants who are currently receiving chronic (\> 14 days) treatment with corticosteroids at a dose \> 10 mg of prednisone (or its glucocorticoid equivalent) per day, or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug.