Investigation of Antitumor Activity of INCB059872 in Ewing Sarcoma
Research type
Research Study
Full title
An Open-Label Phase 1b Study of the Safety, Tolerability, and Preliminary Antitumor Activity of INCB059872 in Participants With Relapsed or Refractory Ewing Sarcoma
IRAS ID
209302
Contact name
Martin McCabe
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2018-000062-11
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
This is an early phase (1b) open-label study designed to evaluate the safety and preliminary antitumour activity of INCB059872 in participants with Ewing sarcoma who are refractory or relapsed from prior standard therapy and not eligible for further standard systemic therapy. Ewing sarcoma acts on the bone and/or soft tissue and primarily afflicts adolescents and young adults. Although there is a first line treatment, but no standard second-line treatment leaving no options.
INCB059872 is a small-molecule selective inhibitor of LSD1, belonging to the class of cyclopropylamine derivatives. Research suggests a potential targeted strategy for the therapeutic benefit of LSD1 inhibitors in Ewing sarcoma. INCB059872 was tested in several models of human Ewing sarcoma xenograft models in mice. The mice were dosed at 1.5mg/kg once daily for two weeks and it was well tolerated. Based on the human participant data so far for INCB59872-101 the recommended phase 2 dose for transfusion independent patient’s was 3mg every other day. This study, INCB59872-103, includes exploration of 2mg and 3mg QOD dosing starting at 2mg once every other day is therefore clinically reasonable.
Approximately 21 participants will be enrolled, starting with part 1 where safety and tolerability will be evaluated at a starting dose of 2mg once every other day to identify the recommended dose for expansion in Part 2.
Once the recommended dose for expansion is established part 2 will continue in 28 day cycles evaluating the preliminary antitumour activity of the dose whilst still carrying out safety observations (blood monitored, vitals, CT or MRI scans, urine, Electrocardiogram – heart activity, questionnaires and physical examinations.)
There is 30 of days for safety follow-up and the amount of cycles for each participant are based on benefit and having not met criteria for withdraw so participation will vary but is expected to be 4-6 months. This study is sponsored by Incyte corporation.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
18/NW/0793
Date of REC Opinion
30 May 2019
REC opinion
Further Information Favourable Opinion