RECRUITING

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Description

This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.

Conditions

Myeloproliferative Neoplasms
Talk to us

Related Conditions:

Myeloproliferative Neoplasms

Study Overview

On this page

Study Details

Study overview

This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.

A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Condition
Myeloproliferative Neoplasms
Intervention / Treatment

-

Contacts and Locations

Palo Alto

Stanford University, Palo Alto, California, United States, 94304

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Chicago

University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Baltimore

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

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

New York

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

Chapel Hill

University of North Carolina At Chapel Hill, Chapel Hill, North Carolina, United States, 27516

Salt Lake City

Huntsman Cancer Institute At University of Utah, Salt Lake City, Utah, United States, 84112

Milwaukee

Medical College of Wisconsin, Milwaukee, Wisconsin, United States, 53226

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

  • * Age 18 years or older at the time of signing the ICF
  • * ECOG performance status of 0 to 1 for the dose escalation (Part 1a) and 0 to 2 for the dose expansion (Part 1b)
  • * Documented CALR exon-9 mutation
  • * Confirmed diagnosis of MPN according to the 2022 ICC criteria:
  • * DIPSS+ intermediate-2/high-risk MF with prior JAKi, \<20% blasts, and measurable spleen
  • * High-risk ET with platelets \>450×10⁹/L
  • * Resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for MF and ≥2 prior lines for ET
  • * No prior stem cell transplant and none planned within 6 months
  • * Minimum Laboratory Requirements:
  • * Platelet count ≥50 × 10⁹/L
  • * Absolute neutrophil count ≥1 × 10⁹/L
  • * International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤1.5 × upper limit of normal (ULN), unless receiving vitamin K antagonists
  • * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 × ULN
  • * Total bilirubin \<2 × ULN
  • * Estimated creatinine clearance \>45 or \>30 mL/min (depending on study part)
  • * Major bleeding or thrombosis (e.g., stroke, DVT, PE) within the past 3 months
  • * Active or high-risk HBV, HCV, or HIV infection, or other chronic active infections requiring systemic treatment
  • * Active invasive cancer within the past 2 years, except certain early-stage or low-risk cancers (e.g., resected skin, cervical, thyroid, or prostate cancer)
  • * Pregnant or unwilling to avoid pregnancy or fathering a child during the study and for a defined period after the last dose.

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

2029-12-14