NCT07008118 A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
| NCT ID | NCT07008118 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Incyte Corporation |
| Condition | Myeloproliferative Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2028-03-14 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2025-10-01 with a primary completion date of 2028-03-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, \<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 (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) \<2.5 × ULN * Total bilirubin \<2 × ULN * Estimated creatinine clearance \>45 or \>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.
Contact & Investigator
Incyte Medical Monitor
STUDY DIRECTOR
Incyte Corporation
Frequently Asked Questions
Who can join the NCT07008118 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Myeloproliferative Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07008118 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07008118 currently recruiting?
Yes, NCT07008118 is actively recruiting participants. Contact the research team at medinfo@incyte.com for enrollment information.
Where is the NCT07008118 trial being conducted?
This trial is being conducted at Phoenix, United States, Palo Alto, United States, Denver, United States, Jacksonville, United States and 11 additional locations.
Who is sponsoring the NCT07008118 clinical trial?
NCT07008118 is sponsored by Incyte Corporation. The principal investigator is Incyte Medical Monitor at Incyte Corporation. The trial plans to enroll 120 participants.