Study to Assess Safety and Preliminary Efficacy of Orally Administered JBI-802 in Subjects with Myeloproliferative Neoplasms (MPN) and Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) with Thrombocytosis

Jubilant Therapeutics, Inc.0 sites30 target enrollmentApril 18, 2024

ConditionsMyeloproliferative Neoplasms (MPN)Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN)Essential Thrombocythemia (ET)Cancer - Thrombocythaemia Cancer - Bone Cancer - Leukaemia - Chronic leukaemia Blood - Haematological diseases

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Myeloproliferative Neoplasms (MPN)
Sponsor: Jubilant Therapeutics, Inc.
Enrollment: 30
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 18, 2024

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Jubilant Therapeutics, Inc.

Eligibility Criteria

Inclusion Criteria

•\- Male or female subjects aged greater than 18 years at the time of screening visit.
•For Dose Escalation Phase: Subjects diagnosed with any one of the following:
•Subject with diagnosis of Essential Thrombocythemia (ET) per World Health Organization (WHO) diagnostic criteria for myeloproliferative neoplasms.
•Subject requires treatment in order to lower platelet count based on subject age over 60 or history of thrombosis.
•Subject with Morphologically confirmed diagnosis of MDS/MPN neoplasms, excluding Juvenile Myelomonocytic Leukaemia (JMML), CMML and aCML (Atypical Chronic Myeloid Leukaemia), in accordance with WHO 2016 revised criteria, that is relapsed and/or refractory or intolerant to standard of care and that, in the opinion of the Investigator, subjects who have no available therapies known to provide clinical benefits.
•Subject with Myelodysplastic/myeloproliferative neoplasm.
•For Dose Expansion Phase
•Subjects diagnosed with any one of the following:
•Subject with diagnosis of Essential Thrombocythemia (ET) per WHO diagnostic criteria for myeloproliferative neoplasms which requires treatment in order to lower platelet count based on subject age over 60 or history of thrombosis.
•Subject with diagnosis of Polycythemia Vera (PV) per WHO diagnostic criteria that is relapsed and/or refractory or intolerant to standard of care and that, in the opinion of the Investigator,subjects

Exclusion Criteria

•1\. Subject who is treated with systemic anticancer therapy or biological therapy or an investigational agent within 2 weeks or 5 half\-lives, whichever is shorter, prior to start of study drug treatment.
•For MF subject who come off JAK2 antagonists or hydroxyurea, shorter washout is permitted as these subject progress quickly after treatment discontinuation and remain eligible (steroids must be stop at least 7 day before start of study drug treatment)
•Subject who is in need of immediate cytoreduction should be excluded
•2\. Subject who has undergone autologous/allogeneic Haematopoietic Stem Cell Transplantation (HSCT) therapy within 60 days of the first dose of study drug, or subject on immunosuppressive therapy post\-HSCT at the time of screening, or currently with clinically significant Graft\-Versus\- Host Disease (GVHD) as per treating physician (subjects in relapse after allogeneic transplantation must be off treatment with systemic immunosuppressive agents for at least 4 weeks prior to screening.
•3\. Subject with major surgery less than or equal to 21 days prior to starting study drug or has not recovered from adverse effects of such procedure.
•4\. Subject who underwent surgery (e.g., stomach bypass) or medical condition that might significantly affect absorption of medicines.
•5\. Subject who underwent radiotherapy within 2 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment). Subjects must have recovered from all radiotherapy\-related toxicities.
•6\. Subject with known malignant central nervous system disease other than neurologically stable, treated brain metastases– defined as metastasis having no evidence of progression or hemorrhage for at least 4 weeks after treatment (including brain radiotherapy). Must be off any systemic corticosteroids for the treatment of symptomatic brain metastases for at least 14 days prior to enrollment.
•7\. Subject with severe or unstable medical condition, such as congestive heart failure ischemic heart disease, uncontrolled hypertension, uncontrolled diabetes mellitus, psychiatric condition, as well as an uncontrolled cardiac arrhythmia requiring medication ( less than or equal to Grade 2, according to NCI CTCAE Version 5\), myocardial infarction within 6 months prior to starting study treatment, or any other significant or unstable concurrent cardiac illness.
•8\. Subject with congenital long QT syndrome or corrected QT interval by Fridericia (QTcF interval) greater than 450 msec for males and greater than 470 msec for females at screening.