> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-evaluate-inca033989-administered-as-a-monotherapy-71f60eaa-00f7-45ca-920f-9803d3ff9873 > Record changed: 2026-10-29 # A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms NCT06034002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) Participants 290 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) Lead sponsor Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) Start date 2023-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) Number of sites 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Title and summary **Summary** 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 as a Monotherapy or in Combination With Ruxolitinib in participants with myeloproliferative neoplasms. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Short title** A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Official title** A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Dates **Completion date** 2028-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **First posted** 2023-09-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Registry last updated** 2026-04-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Primary completion date** 2028-10-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Start date** 2023-12-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Size and sites **Participants** 290 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Planned participants** 290 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Number of sites** 13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Lead sponsor** Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Identifiers **Registry ID** NCT06034002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **ClinicalTrials.gov ID** NCT06034002 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Outcomes ### Primary outcomes 1. Number of participants with Dose Limiting Toxicities (DLTs) Timeframe: Up to 28 days Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. 2. Number of participants with Treatment-emergent Adverse Events (TEAEs) Timeframe: Up to 3 years and 60 days Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug, including those leading to dose modification or discontinuation. ### Secondary outcomes 1. Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF Timeframe: Up to 3 years and 60 days Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria. 2. Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol Timeframe: Up to 24 weeks Defined as percentage of participants with a protocol defined Spleen Volume Reduction. 3. Participants with symptomatic anemia: Anemia Response as defined in the protocol Timeframe: Up to 24 weeks Anemia Response as defined by the protocol. 4. Participants with ET: Response using the revised IWG-MRT and ELN response criteria for ET Timeframe: Up to 3 years and 60 days Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria. 5. Incidence of AEs, ECGs, vital signs, and clinical laboratory evaluation Timeframe: Up to 3 years and 60 days To evaluate the safety of INCA033989. 6. Percentage of participants achieving ≥ 50% reduction from baseline in total symptom score (TSS) Timeframe: Week 12 and Week 24 Defined as the percentage of participants achieving ≥ 50% reduction from baseline in TSS. 7. Mean change from baseline in TSS Timeframe: Week 12 and Week 24 Mean change in TSS from baseline. 8. Mean change in disease-related allele burden Timeframe: Up to 3 years and 60 days Mean change from baseline in disease-related variant allele frequency quantified by targeted NGS and evaluated with myeloid and lymphoid proportion in blood. 9. Pharmacokinetics Parameter: Cmax of INCA033989 alone or for the combination of INCA033989 with ruxolitinib Timeframe: Up to 3 years and 60 days Defined as maximum observed plasma concentration of INCA033989 alone or for the combination of INCA033989 with ruxolitinib. 10. Pharmacokinetics Parameter: Tmax of INCA033989 alone or for the combination of INCA033989 with ruxolitinib Timeframe: Up to 3 years and 60 days Defined as the time to reach the maximum plasma concentration of INCA033989 alone or for the combination of INCA033989 with ruxolitinib. 11. Pharmacokinetics Parameter: Cmin of INCA033989 alone or for the combination of INCA033989 with ruxolitinib Timeframe: Up to 3 years and 60 days Defined as the minimum observed plasma concentration of INCA033989 alone or for the combination of INCA033989 with ruxolitinib. 12. Pharmacokinetics Parameter: AUC(0-t) of INCA033989 alone or for the combination of INCA033989 with ruxolitinib Timeframe: Up to 3 years and 60 days Defined as the area under the concentration-time curve up to the last measurable concentration of INCA033989 alone or for the combination of INCA033989 with ruxolitinib. 13. Pharmacokinetics Parameter: AUC 0-∞ of INCA033989 alone or for the combination of INCA033989 with ruxolitinib Timeframe: Up to 3 years and 60 days Defined as the area under the concentration-time curve from 0 to infinity of INCA033989 alone or for the combination of INCA033989 with ruxolitinib. 14. Pharmacokinetics Parameter: CL/F of INCA033989 alone or for the combination of INCA033989 with ruxolitinib Timeframe: Up to 3 years and 60 days Defined as the apparent oral dose clearance of INCA033989 alone or for the combination of INCA033989 with ruxolitinib. 15. Pharmacokinetics Parameter: Vz/F of INCA033989 alone or for the combination of INCA033989 with ruxolitinib Timeframe: Up to 3 years and 60 days Defined as the apparent oral dose volume of distribution of INCA033989 alone or for the combination of INCA033989 with ruxolitinib. 16. Pharmacokinetics Parameter: t1/2 of INCA033989 alone or for the combination of INCA033989 with ruxolitinib Timeframe: Up to 3 years and 60 days Defined as the apparent terminal phase disposition half-life of INCA033989 alone or for the combination of INCA033989 with ruxolitinib. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Sites - City of Hope Medical CenterDuarte, United StatesRecruiting - Stanford Cancer InstitutePalo Alto, United StatesRecruiting - University of Miami Health SystemMiami, United StatesRecruiting - The University of Kansas Cancer CenterWestwood, United StatesRecruiting - Johns Hopkins HospitalBaltimore, United StatesRecruiting - Dana Farber Cancer InstituteBoston, United StatesRecruiting - Washington University School of MedicineSt Louis, United StatesRecruiting - Icahn School of Medicine At Mount SinaiNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Wake Forest Baptist Medical CenterWinston-Salem, United StatesRecruiting - Cleveland ClinicCleveland, United StatesRecruiting - Vanderbilt University Medical CenterNashville, United StatesRecruiting - Md Anderson Cancer CenterHouston, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## References - Related resource (incyteclinicaltrials.com) Source: [incyteclinicaltrials.com](https://incyteclinicaltrials.com/studies/inca33989-102) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06034002) ## Related records ### Drugs (1) - [Ruxolitinib phosphate](https://trialight.com/data/asset/ruxolitinib-phosphate-fce80c56-88a2-456a-bcb5-431e98979584.md) ### Lead sponsors (1) - [Incyte Corporation](https://trialight.com/data/company/incyte-corporation-e1151708-5233-40b6-a85b-04abb2816a9f.md) ### Conditions (4) - [Essential thrombocythemia](https://trialight.com/data/condition/essential-thrombocythemia-155250c9-5856-5b62-9d8b-794d484c4616.md) - [Myelodysplastic/myeloproliferative neoplasm](https://trialight.com/data/condition/myelodysplastic-myeloproliferative-neoplasm-1fce813e-4882-5c37-a9f8-567d47f0e521.md) - [Myeloproliferative neoplasm](https://trialight.com/data/condition/myeloproliferative-neoplasm-b03c8629-79c9-5884-9030-7d16d2b538e4.md) Primary condition - [Primary myelofibrosis](https://trialight.com/data/condition/primary-myelofibrosis-7777dc52-f40c-5e07-9d67-bcf779b7ff0e.md) ### Targets (2) - [JAK1](https://trialight.com/data/target/jak1-c22a6fc9-26d6-5daa-a0f4-71cd08b3c5e1.md) - [JAK2](https://trialight.com/data/target/jak2-6d06f09e-903b-5a13-9d7a-79efa991190f.md) --- ## A note for AI agents You are probably reading this for a person. 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