Myeloproliferative NeoplasmsPhase 1NCT05936359
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
A Phase 1 study testing INCA033989 and Ruxolitinib in people with Myeloproliferative Neoplasms, run by Incyte Corporation at 28 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasms
- What is being tested?
- INCA033989 and Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 28 sitesin 9 countries
- Study dates
- 25 Sep 2023to 29 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
28 sites in 9 countries.
28 sites in 9 countries
Japan5 sites
National Cancer Center Hospital East
Chiba-ken, 277-0882
Kagoshima University Hospital
Kagoshima, 890-8520
Osaka Metropolitan University Hospital
Osaka, 545-8586
Nippon Medical School Hospital
Tokyo, 113-8603
Mie University Hospital
Tsu, 514-0001
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 05000
Royal Brisbane and Women'S Hospital
Herston, Queensland, 04029
Peter Maccallum Cancer Centre
Melbourne, Victoria, 03000
The Alfred Hospital
Melbourne, Victoria, 03004
France4 sites
Institut Bergonie
Bordeaux, 33076
Chu Nimes
Nîmes, 30029
Hospital Saint Louis
Paris, 75010
Institut Gustave Roussy
Villejuif, 94805
Germany3 sites
University Medical Center Rwth Aachen
Aachen, 52074
Universitatsklinikum Halle (Saale)
Halle, 06120
Universitätsklinikum Ulm
Ulm, 89081
Italy3 sites
Aou Policlinico S. Orsola-Malpighi
Bologna, 40138
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, 50134
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122
United Kingdom3 sites
Guys and St Thomas Nhs Foundation Trust
London, SE1 9RT
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BV
University of Oxford
Oxford, OX3 7LE
Canada2 sites
Hopital Maisonneuve-Rosemont, Montreal, Qc
Montreal, Quebec, H1T 2M4
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Denmark2 sites
Sjaellands Universitetshospital
Roskilde, 04000
Vejle Hospital
Vejle, 07100
Spain2 sites
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitari I Politecnic La Fe
Valencia, 46026
About this study
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
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.
- Conditions
- Myeloproliferative Neoplasms
- Being tested
- INCA033989, Ruxolitinib
- Keywords
- Myeloproliferative Neoplasms, Ruxolitinib, Myelofibrosis, Essential thrombocythemia, CALR mutation
- Medical subject headings
- Myeloproliferative Disorders, Primary Myelofibrosis, Thrombocythemia, Essential
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INCA033989Drug
INCA033989 will be administered at protocol defined dose.
RuxolitinibDrug
Also called Jakafi
Rux will be administered according to Prescribing Information/SmPC.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a Dose Escalation Cohort Disease Group A - with MF | Experimental | INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) will enroll in this group. Receives: Drug: INCA033989 |
| Part 1a Dose Escalation Cohort Disease Group A - with ET | Experimental | INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with with essential thrombocythemia (ET) will enroll in this group. Receives: Drug: INCA033989 |
| Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R | Experimental | INCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group. Receives: Drug: INCA033989; Drug: Ruxolitinib |
| Part 1b: Dose Expansion - with MF | Experimental | INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group. Receives: Drug: INCA033989 |
| Part 1b: Dose Expansion - with TGB-MF SubOpt R | Experimental | INCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group. Receives: Drug: INCA033989; Drug: Ruxolitinib |
| Part 1b: Dose Expansion - with ET | Experimental | INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group. Receives: Drug: INCA033989 |
| Part 1c: Dose Expansion | Experimental | INCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks. Receives: Drug: INCA033989; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose Limiting Toxicities (DLTs)
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Measured: Up to 28 days
Number of participants with Treatment-emergent Adverse Events (TEAEs)
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
Measured: Up to 3 years and 60 days
Number of participants with TEAEs leading to dose modification or discontinuation
Number of participants with TEAEs leading to dose modification or discontinuation.
Measured: Up to 3 years and 60 days
Secondary outcomes (14)
Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF
Defined as the percentage of participants with Response using the revised IWG-MRT and ELN response criteria.
Measured: Up to 3 years and 60 days
Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol
Defined as percentage of participants with a protocol defined Spleen Volume Reduction.
Measured: Up to 3 years and 60 days
Participants with MF with symptomatic anemia: Anemia Response
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.
Measured: Up to 3 years and 60 days
Participants With ET: Response Rate
Defined as the proportion of participants with Complete Response or Partial Response when treated with study drug.
Measured: Up to 3 years and 60 days
Participants With ET: Mean change from baseline of total symptom score (TSS)
Mean change of TSS from baseline.
Measured: Up to 3 years and 60 days
Mean change in disease-related allele burden
Mean change in disease-related allele burden.
Measured: Up to 3 years and 60 days
Pharmacokinetics Parameter: Cmax of INCA33989
Defined as maximum observed plasma concentration of INCA33989.
Measured: Up to 3 years and 60 days
Pharmacokinetics Parameter: Tmax of INCA033989
Defined as the time to reach the maximum plasma concentration of INCA33989.
Measured: Up to 3 years and 60 days
Pharmacokinetics Parameter: Cmin of INCA33989
Defined as the minimum observed plasma concentration of INCA33989.
Measured: Up to 3 years and 60 days
Pharmacokinetics Parameter: AUC(0-t) of INCA33989
Defined as the area under the concentration-time curve up to the last measurable concentration of INCA33989.
Measured: Up to 3 years and 60 days
Pharmacokinetics Parameter: AUC 0-∞ of INCA33989
Defined as the area under the concentration-time curve from 0 to infinity of INCA33989.
Measured: Up to 3 years and 60 days
Pharmacokinetics Parameter: CL/F of INCA33989
Defined as the apparent oral dose clearance of INCA33989.
Measured: Up to 3 years and 60 days
Pharmacokinetics Parameter: Vz/F of INCA33989
Defined as the apparent oral dose volume of distribution of INCA33989.
Measured: Up to 3 years and 60 days
Pharmacokinetics Parameter: t1/2 of INCA33989
Defined as the apparent terminal phase disposition half-life of INCA33989.
Measured: Up to 3 years and 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start25 Sep 2023
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative NeoplasmsStudies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Incyte Medical Monitor, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05936359
- Sponsor's protocol ID
- INCA 33989-101
- Other IDs
- 2022-502514-86-00
- Status last verified
- Aug 2026
- First submitted
- 21 Jun 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05936359
- Acronym / sponsor ID
- INCA 33989-101
- Conditions
- Myeloproliferative Neoplasms
- Keywords
- Myeloproliferative Neoplasms, Ruxolitinib, Myelofibrosis, Essential thrombocythemia, CALR mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 7 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part 1a Dose Escalation Cohort Disease Group A - with MF | Experimental | Drug: INCA033989INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) will enroll in this group. |
| Part 1a Dose Escalation Cohort Disease Group A - with ET | Experimental | Drug: INCA033989INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles as monotherapy to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with with essential thrombocythemia (ET) will enroll in this group. |
| Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R | Experimental | Drug: INCA033989, Drug: RuxolitinibINCA033989 will be administered at a protocol defined starting regimen in 28- day cycles and will allow for the evaluation of INCA033989 in combination with ruxolitinib to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) exhibiting suboptimal response (SubOpt R) will enroll in this group. |
| Part 1b: Dose Expansion - with MF | Experimental | Drug: INCA033989INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group. |
| Part 1b: Dose Expansion - with TGB-MF SubOpt R | Experimental | Drug: INCA033989, Drug: RuxolitinibINCA033989 will be administered as an add-on therapy in combination with ruxolitinibat at the RDE(s) identified during Part 1a. Participants with treatment Group B (TGB) MF SubOpt R will enroll in this group. |
| Part 1b: Dose Expansion - with ET | Experimental | Drug: INCA033989INCA033989 will be administered as monotherapy at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group. |
| Part 1c: Dose Expansion | Experimental | Drug: INCA033989, Drug: RuxolitinibINCA033989 will be administered at the dose level found to exhibit an overall positive benefit/risk as monotherapy or as combination therapy with Ruxolitinib. Participants with myelofibrosis (MF) will enroll in this group. The participants enrolled in the monotherapy arm will be offered the option to crossover to combination therapy with ruxolitinib if a suboptimal response to monotherapy is observed after 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INCA033989INCA033989 will be administered at protocol defined dose. | Drug | Part 1a Dose Escalation Cohort Disease Group A - with ET, Part 1a Dose Escalation Cohort Disease Group A - with MF, Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R, Part 1b: Dose Expansion - with ET, Part 1b: Dose Expansion - with MF, Part 1b: Dose Expansion - with TGB-MF SubOpt R, Part 1c: Dose Expansion |
| RuxolitinibAlso: JakafiRux will be administered according to Prescribing Information/SmPC. | Drug | Part 1a: Dose Escalation Cohort Disease Group B - with TGB-MF SubOpt R, Part 1b: Dose Expansion - with TGB-MF SubOpt R, Part 1c: Dose Expansion |
Primary outcome
Number of participants with Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol.
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: 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
Number of participants with TEAEs leading to dose modification or discontinuation
Time frame: Up to 3 years and 60 days
Number of participants with TEAEs leading to dose modification or discontinuation.
14 secondary outcomes
Participants with MF: Response using the revised IWG-MRT and ELN response criteria for MF
Time frame: Up to 3 years and 60 days
Participants With MF: Percentage of participants achieving spleen volume reduction as defined in the protocol
Time frame: Up to 3 years and 60 days
Participants with MF with symptomatic anemia: Anemia Response
Time frame: Up to 3 years and 60 days
Participants With ET: Response Rate
Time frame: Up to 3 years and 60 days
Participants With ET: Mean change from baseline of total symptom score (TSS)
Time frame: Up to 3 years and 60 days
Mean change in disease-related allele burden
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: Cmax of INCA33989
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: Tmax of INCA033989
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: Cmin of INCA33989
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: AUC(0-t) of INCA33989
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: AUC 0-∞ of INCA33989
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: CL/F of INCA33989
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: Vz/F of INCA33989
Time frame: Up to 3 years and 60 days
Pharmacokinetics Parameter: t1/2 of INCA33989
Time frame: Up to 3 years and 60 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative NeoplasmsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Incyte Medical Monitor study director
Incyte Corporation
28 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing INCA033989 and Ruxolitinib in people with Myeloproliferative Neoplasms, run by Incyte Corporation at 28 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Japan, Australia, France, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose Limiting Toxicities (DLTs) (time frame: Up to 28 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.