> 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-8451c82e-c021-4c6b-8cdf-3dede41b0f4b > Record changed: 2026-10-13 # A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms NCT05936359 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) Lead sponsor Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) Start date 2023-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) Number of sites 28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## Title and summary **Summary** This study is being conducted to evaluate the safety, tolerability, and 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/NCT05936359) **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/NCT05936359) **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/NCT05936359) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## Dates **Completion date** 2028-02-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **First posted** 2023-07-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Registry last updated** 2026-08-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Primary completion date** 2028-02-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Start date** 2023-09-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## Size and sites **Actual participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Number of sites** 28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Lead sponsor** Incyte Corporation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## Identifiers **Registry ID** NCT05936359 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **ClinicalTrials.gov ID** NCT05936359 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## 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 monotherapy and in combination with ruxolitinib 3. Number of participants with TEAEs leading to dose modification or discontinuation Timeframe: Up to 3 years and 60 days Number of participants with TEAEs 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 3 years and 60 days Defined as percentage of participants with a protocol defined Spleen Volume Reduction. 3. Participants with MF with symptomatic anemia: Anemia Response Timeframe: Up to 3 years and 60 days 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. 4. Participants With ET: Response Rate Timeframe: Up to 3 years and 60 days Defined as the proportion of participants with Complete Response or Partial Response when treated with study drug. 5. Participants With ET: Mean change from baseline of total symptom score (TSS) Timeframe: Up to 3 years and 60 days Mean change of TSS from baseline. 6. Mean change in disease-related allele burden Timeframe: Up to 3 years and 60 days Mean change in disease-related allele burden. 7. Pharmacokinetics Parameter: Cmax of INCA33989 Timeframe: Up to 3 years and 60 days Defined as maximum observed plasma concentration of INCA33989. 8. Pharmacokinetics Parameter: Tmax of INCA033989 Timeframe: Up to 3 years and 60 days Defined as the time to reach the maximum plasma concentration of INCA33989. 9. Pharmacokinetics Parameter: Cmin of INCA33989 Timeframe: Up to 3 years and 60 days Defined as the minimum observed plasma concentration of INCA33989. 10. Pharmacokinetics Parameter: AUC(0-t) of INCA33989 Timeframe: Up to 3 years and 60 days Defined as the area under the concentration-time curve up to the last measurable concentration of INCA33989. 11. Pharmacokinetics Parameter: AUC 0-∞ of INCA33989 Timeframe: Up to 3 years and 60 days Defined as the area under the concentration-time curve from 0 to infinity of INCA33989. 12. Pharmacokinetics Parameter: CL/F of INCA33989 Timeframe: Up to 3 years and 60 days Defined as the apparent oral dose clearance of INCA33989. 13. Pharmacokinetics Parameter: Vz/F of INCA33989 Timeframe: Up to 3 years and 60 days Defined as the apparent oral dose volume of distribution of INCA33989. 14. Pharmacokinetics Parameter: t1/2 of INCA33989 Timeframe: Up to 3 years and 60 days Defined as the apparent terminal phase disposition half-life of INCA33989. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## 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 and ET as defined in the protocol. ### Exclusion criteria - Presence of any hematological malignancy other than ET, PMF, or post-ET MF. - Active invasive malignancy over the previous 2 years. - Active HBV/HCV, HIV. - History of clinically significant or uncontrolled cardiac disease. - Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned. - Laboratory values outside the Protocol-defined ranges. - 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. - Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment. - 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. - For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study. Other protocol-defined Inclusion/Exclusion Criteria may apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## Sites - Royal Brisbane and Women'S HospitalHerston, Australia - Royal Adelaide HospitalAdelaide, Australia - Peter Maccallum Cancer CentreMelbourne, Australia - The Alfred HospitalMelbourne, Australia - Princess Margaret Cancer CenterToronto, Canada - Hopital Maisonneuve-Rosemont, Montreal, QcMontreal, Canada - Sjaellands UniversitetshospitalRoskilde, Denmark - Vejle HospitalVejle, Denmark - Institut BergonieBordeaux, France - Chu NimesNîmes, France - Hospital Saint LouisParis, France - Institut Gustave RoussyVillejuif, France - University Medical Center Rwth AachenAachen, Germany - Universitatsklinikum Halle (Saale)Halle, Germany - Universitätsklinikum UlmUlm, Germany - Aou Policlinico S. Orsola-MalpighiBologna, Italy - Azienda Ospedaliero-Universitaria Careggi (Aouc)Florence, Italy - Fondazione Irccs Ca Granda Ospedale MaggioreMilan, Italy - National Cancer Center Hospital EastChiba-ken, Japan - Kagoshima University HospitalKagoshima, Japan - Osaka Metropolitan University HospitalOsaka, Japan - Nippon Medical School HospitalTokyo, Japan - Mie University HospitalTsu, Japan - Hospital Universitario 12 de OctubreMadrid, Spain - Hospital Universitari I Politecnic La FeValencia, Spain And 3 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## References - Related resource (incyteclinicaltrials.com) Source: [incyteclinicaltrials.com](https://incyteclinicaltrials.com/studies/inca-33989-101) ### Other registry identifiers - 2022-502514-86-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05936359) ## 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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