A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms

Description

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 INCA033989 administered in participants with myeloproliferative neoplasms.

Conditions

Myeloproliferative Neoplasms

Talk to us

Study Overview

On this page

Study Details

Study overview

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 INCA033989 administered in participants with myeloproliferative neoplasms.

A Phase 1, Open-Label, Multicenter Study of INCA033989 in Participants With Myeloproliferative Neoplasms

A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms

Condition
Myeloproliferative Neoplasms
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope Medical Center, Duarte, California, United States, 91010

Palo Alto

Stanford Cancer Institute, Palo Alto, California, United States, 94304

Miami

University of Miami Health System, Miami, Florida, United States, 33136

Tampa

Moffitt Cancer Center, Tampa, Florida, United States, 33612

Westwood

The University of Kansas Cancer Center, Westwood, Kansas, United States, 66205

Baltimore

Johns Hopkins Hospital, Baltimore, Maryland, United States, 21287

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63108

New York

Icahn School of Medicine At Mount Sinai, New York, New York, United States, 10029

New York

Memorial Sloan Kettering Cancer Center, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 or ET as defined in the protocol.
  • * 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 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Incyte Medical Monitor, STUDY_DIRECTOR, Incyte Corporation

Study Record Dates

2028-10-29