Myeloproliferative NeoplasmsPhase 1NCT07008118
A Study to Evaluate INCA035784 in Participants With Myeloproliferative Neoplasms
A Phase 1 study testing INCA035784 in people with Myeloproliferative Neoplasms, run by Incyte Corporation at 26 sites in 5 countries.
Trial summary
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasms
- What is being tested?
- INCA035784
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 26 sitesin 5 countries
- Study dates
- 1 Oct 2025to 14 Dec 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
Trial locations and contacts
26 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
26 sites in 5 countries
United States12 sites, 12 recruiting
- Recruiting
South Austin Medical Center
Austin, Texas, 78704
- Recruiting
Johns Hopkins University
Baltimore, Maryland, 21287
- Recruiting
University of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27514
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
University of Texas Southwestern Medical Center Harold C Simmons Comprehensive Cancer Center Blood
Dallas, Texas, 75235
- Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, 80218
- Recruiting
Mayo Clinic-Florida
Jacksonville, Florida, 32224
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Recruiting
Icahn School of Medicine At Mount Sinai
New York, New York, 10029
- Recruiting
Stanford University
Palo Alto, California, 94304
- Recruiting
Mayo Clinic Hospital
Phoenix, Arizona, 85054
- Recruiting
Huntsman Cancer Institute At University of Utah
Salt Lake City, Utah, 84112
Australia4 sites, 4 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 05000
- Recruiting
The Alfred Hospital
Melbourne, Victoria, 03004
- Recruiting
Linear Clinical Research
Nedlands, Western Australia, 06009
- Recruiting
Macquarie University Hospital
Sydney, New South Wales, 02109
Italy4 sites, 4 recruiting
- Not yet recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Bergamo, 24127
- Not yet recruiting
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
Florence, 50134
- Not yet recruiting
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122
- Not yet recruiting
Centro Ricerche Cliniche Di Verona
Verona, 37134
Belgium3 sites, 3 recruiting
- Not yet recruiting
Cliniques Universitaires Saint-Luc
Brussels, 01200
- Not yet recruiting
Universitair Ziekenhuis Gent
Ghent, 09000
- Not yet recruiting
Universitaire Ziekenhuizen Leuven
Leuven, 03000
Germany3 sites, 3 recruiting
- Not yet recruiting
Universitaetsklinikum Dresden
Dresden, 01307
- Not yet recruiting
Universitatsklinikum Halle (Saale)
Halle, 06120
- Not yet recruiting
Universitatsmedizin Der Johannes Gutenberg-Universitat Mainz Iii
Mainz, 55131
About this study
Official title: A Phase 1, Open-Label, Multicenter Study of INCA035784 in Participants With Myeloproliferative Neoplasms
This study is being conducted to evaluate the safety and tolerability of INCA035784 in participants with myeloproliferative neoplasms.
- Conditions
- Myeloproliferative Neoplasms
- Being tested
- INCA035784
- Keywords
- Myeloproliferative Neoplasms, Myelofibrosis, Essential thrombocythemia, CALR mutation
- Medical subject headings
- Myeloproliferative Disorders, Primary Myelofibrosis, Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCA035784Drug
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 group | Role | What they receive |
|---|---|---|
| Part 1a: Dose escalation | Experimental | INCA035784 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myeloproliferative neoplasm (MPN) will enroll in this group. Receives: Drug: INCA035784 |
| Part 1b: Dose expansion | Experimental | INCA035784 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with myeloproliferative neoplasm (MPN) will enroll in this group. Receives: Drug: INCA035784 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Measured: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
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.
Measured: Up to approximately 2 years and 90 days
Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay
Number of participants with TEAEs leading to treatment interruption, discontinuation, or delay.
Measured: Up to approximately 2 years and 90 days
Secondary outcomes (16)
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Measured: Up to approximately 2 years and 90 days
Participants with MF: Response using the revised International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) and European LeukemiaNet (ELN) response criteria for myelofibrosis (MF)
Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.
Measured: Up to approximately 2 years and 90 days
Participants with essential thrombocythemia (ET): Response using the revised IWG-MRT and ELN response criteria for ET
Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.
Measured: Up to approximately 2 years and 90 days
Participants with symptomatic anemia: Anemia response
Anemia response as defined in the protocol.
Measured: Up to approximately 2 years and 90 days
Participants with spleen volume (SV) ≥ 450 mL at baseline: Percentage of participants achieving spleen volume reduction of ≥ 35% (SVR35)
Defined as percentage of participants with a protocol defined Spleen Volume Reduction of ≥ 35% (SVR35).
Measured: Week 12 and Week 24
Participants with SV ≥ 450 mL at baseline: Percentage of participants achieving spleen volume reduction of ≥ 25% (SVR25)
Defined as percentage of participants with a protocol defined Spleen Volume Reduction of ≥ 25% (SVR25).
Measured: Week 12 and Week 24
Percentage of participants achieving ≥ 50% reduction from baseline of total symptom score (TSS)
Defined as the percentage of participants achieving ≥ 50% reduction from baseline of TSS.
Measured: Week 12 and Week 24
Mean change from baseline in TSS
Mean change of TSS from baseline.
Measured: Week 12 and Week 24
Pharmacokinetics Parameter (PK): Cmax of INCA035784
Defined as maximum observed plasma concentration of INCA035784.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Tmax of INCA035784
Defined as the time to reach the maximum plasma concentration of INCA035784.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Cmin of INCA035784
Defined as the minimum observed plasma concentration of INCA035784.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: AUC(0-t) of INCA035784
Defined as the area under the concentration-time curve up to the last measurable concentration of INCA035784.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: AUC 0-∞ of INCA035784
Defined as the area under the concentration-time curve from 0 to infinity of INCA035784.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: CL of INCA035784
Defined as the apparent oral dose clearance of INCA035784.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: Vz of INCA035784
Defined as the apparent oral dose volume of distribution of INCA035784.
Measured: Up to approximately 2 years and 90 days
Pharmacokinetics Parameter: t1/2 of INCA035784
Defined as the apparent terminal phase disposition half-life of INCA035784.
Measured: Up to approximately 2 years and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Oct 2025
- Primary completion14 Mar 2028 (estimated)
- Study completion14 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008118
- Sponsor's protocol ID
- INCA035784-101
- Status last verified
- Aug 2026
- First submitted
- 29 May 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No