INCA036978 for people with myeloproliferative neoplasms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, dose-escalation trial designed to define safety, dose-limiting toxicities, and the maximum tolerated dose or recommended dose for expansion of INCA036978 when used alone or combined with standard disease-directed therapy. Participants will receive ascending doses of INCA036978 and will be monitored closely for adverse events, laboratory changes, and disease-specific markers. Pretreatment and limited on-study bone marrow biopsies and aspirates are required as appropriate for the specific MPN subtype. The study excludes patients with other recent malignancies, uncontrolled infections, significant cardiac disease, recent major bleeding or thrombosis, or recent allogeneic stem cell transplant.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Life expectancy \> 6 months.
* Willingness to undergo a pretreatment and limited on-study BM biopsies and aspirates (as appropriate to disease).
* Participants with MF, PV and ET as defined in the protocol.

Exclusion Criteria:

* Presence of any hematological malignancy other than MF, PV, or ET.
* Malignancy within the last 3 years prior to enrollment.
* Acute or chronic HBV, Active HCV or known HIV or tuberculosis infection.
* Clinically significant or uncontrolled cardiac disease.
* Has undergone any prior allogeneic stem-cell transplantation or such transplantation is planned in the next 6 months.
* Laboratory values outside the Protocol-defined ranges.
* Prior history of major bleeding or thrombosis within the last 3 months prior to study enrollment.
* Presence of chronic or current active infectious disease requiring systemic treatment.
* Treatment with an MPN-directed therapy (approved or investigational) within the per protocol threshold before the administration of study drug.
* Prior radiation therapy within 28 days before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where it's running

• City of Hope-Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• Winship Cancer Institute of Emory University
  Atlanta, Georgia, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• University of North Carolina At Chapel Hill
  Chapel Hill, North Carolina, United States Recruiting
• Ohio State University
  Columbus, Ohio, United States Recruiting
• Tristar Bmt/Tcto
  Nashville, Tennessee, United States Recruiting

+4 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)
• Email: medinfo@incyte.com
• Phone: 1.855.463.3463

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• MPN PROGRESSion Registry — tracking symptoms, treatments, and disease progression in people with MPNs.

  Track long-term symptoms, treatments, and disease progression in adults with myeloproliferative neoplasms to see how these conditions evolve over time.

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• INCA035784 for people with CALR‑mutated myeloproliferative neoplasms (myelofibrosis or essential thrombocythemia)

  This trial tests whether INCA035784 is safe and tolerable in adults with CALR‑mutated myeloproliferative neoplasms who have already received prior therapies.

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• Combining Ivosidenib and Ruxolitinib for Advanced Myeloproliferative Neoplasms with IDH1 Mutation

  This study is testing if combining two medications, ivosidenib and ruxolitinib, can help people with advanced myeloproliferative neoplasms that have an IDH1 mutation feel better and improve their treatment outcomes.

  Recruiting at 2 sites Phase 1 University of Chicago · Chicago, Illinois and 1 other locations · NCT06291987

• Evaluating INCA033989 for treating myeloproliferative neoplasms

  This study is testing a new treatment called INCA033989, alone and with another drug, to see if it’s safe and effective for people with myeloproliferative neoplasms who have certain mutations.

  Recruiting at 13 sites Phase 1 Incyte Corporation · Duarte, California and 12 other locations · NCT06034002

• Hematopoietic stem cell transplant for blood cancers

  This study is testing two different ways of doing stem cell transplants for people with blood cancers to see which method works better and is safer.

  Recruiting Phase 2 Masonic Cancer Center, University of Minnesota · Minneapolis, Minnesota · NCT03314974

• OURA ring wearable monitoring for adults with myelodysplastic syndromes

  This pilot will test whether adults with MDS can wear an OURA ring regularly and upload biometric data so clinicians can link those measurements with quality of life and transfusion status.

  Recruiting Sunnybrook Health Sciences Centre · Toronto, Ontario · NCT06270771

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.