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Recruiting NCT07008118

A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms

Conditions: Myeloproliferative Neoplasms

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 120
Sponsor: Incyte Corporation

Location: Mayo Clinic Hospital Phoenix Arizona

Summary

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

Eligibility Criteria

Inclusion 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, \450×10⁹/L * Resistant, refractory, intolerant, or has lost response to ≥1 prior line of therapy for MF and ≥2 prior lines for ET (unless only a single standard-of-care option is approved in the participating country) * 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) \30 mL/min (depending on study part) Exclusion Criteria: * 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. Other protocol-defined Inclusion/Exclusion Criteria may apply.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07008118). StuddyBuddy aggregates publicly available trial information.