Clinical Trials in Italy / NCT07008118
Recruiting
Phase 1
A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
NCT07008118 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Myeloproliferative Neoplasms
Investigational drug(s) / intervention(s)
INCA035784
INCA035784: INCA035784 will be administered at the assigned dose in the dose escalation part and at the protocol defined dose in the dose expansion part.
Study summary
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
Eligibility
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.
Primary outcome measure(s)
- Number of participants with Dose Limiting Toxicities (DLTs) — Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. - Number of participants with Treatment-emergent Adverse Events (TEAEs) — Up to approximately 2 years and 90 days
Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug up to 90 days after the last dose of study drug. - Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay — Up to approximately 2 years and 90 days
Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay.
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Hospital | Phoenix | Arizona | Recruiting |
| Stanford University | Palo Alto | California | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | Recruiting |
| Mayo Clinic-Florida | Jacksonville | Florida | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| Johns Hopkins University | Baltimore | Maryland | Recruiting |
| Icahn School of Medicine At Mount Sinai | New York | New York | Recruiting |
| University of North Carolina At Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| South Austin Medical Center | Austin | Texas | Recruiting |
| University of Texas Southwestern Medical Center Harold C Simmons Comprehensive Cancer Center Blood | Dallas | Texas | Recruiting |
| Huntsman Cancer Institute At University of Utah | Salt Lake City | Utah | Recruiting |
| Medical College of Wisconsin | Milwaukee | Wisconsin | Recruiting |
| Macquarie University Hospital | Sydney | New South Wales | Recruiting |
| Royal Adelaide Hospital | Adelaide | South Australia | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Linear Clinical Research | Nedlands | Western Australia | Recruiting |
| Cliniques Universitaires Saint-Luc | Brussels | Belgium | Not Yet Recruiting |
| Universitair Ziekenhuis Gent | Ghent | Belgium | Not Yet Recruiting |
| Universitaire Ziekenhuizen Leuven | Leuven | Belgium | Not Yet Recruiting |
| Universitaetsklinikum Dresden | Dresden | Germany | Not Yet Recruiting |
| Universitatsklinikum Halle (Saale) | Halle | Germany | Not Yet Recruiting |
| Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii | Mainz | Germany | Not Yet Recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii | Bergamo | Italy | Not Yet Recruiting |
| Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica | Florence | Italy | Not Yet Recruiting |
| Fondazione Irccs Ca Granda Ospedale Maggiore | Milan | Italy | Not Yet Recruiting |
| Centro Ricerche Cliniche Di Verona | Verona | Italy | Not Yet Recruiting |
More Incyte Corporation trials in Italy
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07008118 on ClinicalTrials.gov ↗ ← All trials in Italy