A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms

Study Purpose

This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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 HBV/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 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06034002
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Incyte Corporation
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Incyte Medical Monitor
Principal Investigator Affiliation	Incyte Corporation
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Myeloproliferative Neoplasms

Arms & Interventions

Arms

Experimental: Part 1a Dose Escalation Cohort Disease Group A - with MF

INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) will enroll in this group.

Experimental: Part 1a Dose Escalation Cohort Disease Group A - with ET

Experimental: Part 1b: Dose Expansion - with MF

INCA033989 will be administered at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group.

Experimental: Part 1b: Dose Expansion - with ET

INCA033989 will be administered at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group.

Interventions

Drug: - INCA033989

INCA033989 will be administered at protocol defined dose.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

City of Hope Medical Center, Duarte, California

Status

Recruiting

Address

City of Hope Medical Center

Duarte, California, 91010

Site Contact

[email protected]

1.855.463.3463

Stanford Cancer Institute, Palo Alto, California

Status

Recruiting