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

NCT05936359

Active Not RecruitingPhase 1

Sponsor: Incyte Corporation

Conditions: Myeloproliferative Neoplasms

Interventions: INCA033989, Ruxolitinib

Countries: Australia, Canada, Denmark, France, Germany, Italy, Japan, Spain

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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.

Locations (28)

Herston, Queensland, Australia
Adelaide, South Australia, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Roskilde, Denmark
Vejle, Denmark
Bordeaux, France
Nîmes, France
Paris, France
Villejuif, France
Aachen, Germany
Halle, Germany
Ulm, Germany
Bologna, Italy
Florence, Italy
Milan, Italy
Chiba-ken, Japan
Kagoshima, Japan
Osaka, Japan
Tokyo, Japan
Tsu, Japan
Madrid, Spain
Valencia, Spain
London, United Kingdom
Manchester, United Kingdom
Oxford, United Kingdom