Evaluating INCA033989 for treating myeloproliferative neoplasms

A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With 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.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 290 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Incyte Corporation (industry)
• Drugs / interventions: ruxolitinib, chemotherapy
• Locations: 13 sites (Duarte, California and 12 other locations)
• Trial ID: NCT06034002 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of INCA033989, both alone and in combination with Ruxolitinib, in patients with myeloproliferative neoplasms. It aims to determine the maximum tolerated dose and recommended dose for expansion through a series of assessments including bone marrow biopsies. Participants will be monitored for dose-limiting toxicities and overall treatment response. The study focuses on patients with specific mutations, particularly the CALR mutation.

Who should consider this trial

Good fit: Ideal candidates include individuals with myelofibrosis or essential thrombocythemia who have a documented CALR mutation.

Not a fit: Patients with other hematological malignancies or those who have had recent major bleeding or thrombosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with myeloproliferative neoplasms.

How similar studies have performed: Other studies have shown promise with similar approaches in treating myeloproliferative neoplasms, but this specific combination is being evaluated for the first time.

Eligibility criteria

Inclusion Criteria:

* Life expectancy \> 6 months.
* Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
* Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
* Participants with MF or ET as defined in the protocol.

Exclusion Criteria:

* Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
* Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
* Participants with laboratory values exceeding the protocol defined thresholds.
* Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
* Active invasive malignancy over the previous 2 years.
* History of clinically significant or uncontrolled cardiac disease.
* Active or chronic HBV or active HCV or known history of HIV.
* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease, with the exception of ruxolitinib for TGBs only, within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
* Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Where this trial is running

Duarte, California and 12 other locations

• City of Hope Medical Center — Duarte, California, United States (RECRUITING)
• Stanford Cancer Institute — Palo Alto, California, United States (RECRUITING)
• University of Miami Health System — Miami, Florida, United States (RECRUITING)
• The University of Kansas Cancer Center — Westwood, Kansas, United States (RECRUITING)
• Johns Hopkins Hospital — Baltimore, Maryland, United States (RECRUITING)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (RECRUITING)
• Washington University School of Medicine — St Louis, Missouri, United States (RECRUITING)
• Icahn School of Medicine At Mount Sinai — New York, New York, United States (RECRUITING)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (RECRUITING)
• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
• Md Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Incyte Corporation Call Center (US)

Conditions: Myeloproliferative Neoplasms, Myelofibrosis, Essential thrombocythemia, CALR mutation