Overview

A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

Status:
Recruiting
Trial end date:
2028-02-29
Target enrollment:
0
Participant gender:
All
Summary
This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Incyte Corporation
Criteria
Inclusion Criteria:

- 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 and ET as defined in the protocol.

Exclusion Criteria:

- Presence of any hematological malignancy other than ET, PMF, or post-ET MF.

- Active invasive malignancy over the previous 2 years.

- Active HBV/HCV, HIV.

- History of clinically significant or uncontrolled cardiac disease.

- Has undergone any prior allogenic or autologous stem-cell transplantation or such
transplantation is planned.

- Laboratory values outside the Protocol-defined ranges.

- 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.

- Prior history of major bleeding, or thrombosis within the last 3 months prior to study
enrollment.

- 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 within 5 half-lives or 28 days
(whichever is shorter) before the first dose of study treatment.

- For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP
3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of
study treatment, or expected to receive such treatment during the study.

Other protocol-defined Inclusion/Exclusion Criteria may apply.