A Phase 1 interventional study of INCA036978 and Standard disease-directed therapy in Myeloproliferative Neoplasms, sponsored by Incyte Corporation. Recruiting at 54 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Incyte Corporation · Phase 1, Interventional, and Treatment
This study will be conducted to determine the safety, tolerability, dose-limiting toxicity (DLT)s, and maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)s of INCA036978 administered as monotherapy and in combination with a standard disease-directed therapy.
667 studies on the registry are indexed under Myeloproliferative Disorders; 110 are open to participants now.
This study's planned enrollment of 218 is above the median of 47 across 462 interventional studies indexed under Myeloproliferative Disorders.
Browse Myeloproliferative Disorders studies →Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INCA036978 will be administered at a protocol defined starting regimen as monotherapy to identify the MTD and/or RDE(s).
Drug: INCA036978
INCA036978 will be administered at a protocol defined starting regimen in combination with a standard disease-directed therapy to identify the MTD and/or RDE(s).
Drug: INCA036978 · Drug: Standard disease-directed therapy
INCA036978 will be administered as monotherapy at the RDE(s) identified during Part 1
Drug: INCA036978
INCA036978 will be administered in combination with a standard disease-directed therapy at the RDE(s) identified during Part 1.
Drug: INCA036978 · Drug: Standard disease-directed therapy
INCA036978 will be administered at protocol defined dose.
A standard disease-directed therapy will be administered according to Prescribing Information/SmPC.
Number of participants with Dose Limiting Toxicities (DLT)s in Part 1
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Time frame: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Defined as adverse events AE (either reported for the first time or the worsening of a pre-existing event) occurring after the first dose of study drug and up to 60 days after last dose of study drug or until the start of a new disease-directed therapy, whichever occurs first.
Time frame: Up to approximately 2 years
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to study drug modifications (interruptions, dose reduction) or discontinuation.
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Cmax of INCA036978
Defined as maximum observed plasma concentration of INCA036978.
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Tmax of INCA036978
Defined as the time to reach the maximum plasma concentration of INCA036978.
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Cmax,ss of INCA036978
Defined as the maximum observed plasma concentration at steady state of INCA036978.
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Cmin,ss of INCA036978
Defined as the minimum observed plasma concentration at steady state of INCA036978.
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: AUC(0-t) of INCA036978
Defined as the area under the concentration-time curve up to the last measurable concentration of INCA036978.
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: AUC 0-∞ of INCA036978
Defined as the area under the concentration-time curve from 0 to infinity of INCA036978.
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: CL/F of INCA036978
Defined as the apparent clearance of INCA036978.
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: Vz/F of INCA036978
Defined as the apparent volume of distribution of INCA036978.
Time frame: Up to approximately 2 years
Pharmacokinetics Parameter: t1/2 of INCA036978
Defined as the apparent terminal phase disposition half-life of INCA036978.
Time frame: Up to approximately 2 years
For participants with myelofibrosis (MF): Percentage of participants achieving spleen volume reduction as defined in the protocol
Defined as percentage of participants with a protocol defined spleen volume reduction.
Time frame: Week 12 and Week 24
For participants with MF and anemia: Anemia Response as defined in the protocol
For non transfusion-dependent (TD) participants: An Hb increase relative to baseline as defined in the protocol if non-TD at baseline. For TD participants: Achieving transfusion independency (TI) as defined in the protocol.
Time frame: Up to approximately 2 years
For participants with polycythemia vera (PV): Peripheral blood count remission as defined by the protocol.
Peripheral blood count remission as defined by the protocol.
Time frame: Up to approximately 2 years
For participants with essential thrombocythemia (ET): Peripheral blood count remission as defined by the protocol.
Peripheral blood count remission as defined by the protocol.
Time frame: Up to approximately 2 years
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Myeloproliferative Disorders →