Status:
RECRUITING
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
Lead Sponsor:
Incyte Corporation
Conditions:
Myeloproliferative Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA03...
Eligibility Criteria
Inclusion
- Life expectancy \> 6 months.
- Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
- Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
- Participants with MF or ET as defined in the protocol.
Exclusion
- Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
- Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
- Participants with laboratory values exceeding the protocol defined thresholds.
- Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
- Active invasive malignancy over the previous 2 years.
- History of clinically significant or uncontrolled cardiac disease.
- Active HBV/HCV or known history of HIV.
- Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
- Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.
- Other protocol-defined Inclusion/Exclusion Criteria may apply.
Key Trial Info
Start Date :
December 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 29 2028
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT06034002
Start Date
December 4 2023
End Date
October 29 2028
Last Update
October 30 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
City of Hope Medical Center
Duarte, California, United States, 91010
2
Stanford Cancer Institute
Palo Alto, California, United States, 94304
3
University of Miami Health System
Miami, Florida, United States, 33136
4
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205